ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON

K983478 · Organic Essentials · HEB · Nov 9, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K983478
• Device Name: ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
• Applicant: Organic Essentials
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Nov 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

Organic Essentials Organically Grown Coton Tampon is a tampon that is inserted into the vagina and used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.

Device Story

Organic Essentials Organic Cotton Tampon is a vaginal insert designed for menstrual fluid absorption. Device consists of organic cotton material. Used by female patients for personal hygiene during menstruation. Functions via physical absorption of fluid. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of organic cotton. Form factor is a vaginal tampon. No energy source, software, or electronic components.

Indications for Use

Indicated for use by females for the absorption of menstrual fluid.

Regulatory Classification

Identification

An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 1998 NOV

Ms. La Rhea Pepper President Organic Essentials, Inc. 822 Baldridge Street O'Donnell, TX 79351

Re: K983478

Organic Essentials Organic Cotton Tampon Dated: October 1,1998 Received: October 2,1998 Regulatory Class: II 21 CFR 884.5470/Procode: 85 HEB

Dear Ms. Pepper,

We have reviewed your Section 510K) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and . thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FOA/CDRH/ODE/DMC

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510(k) NUMBER (IF KNOWN): K983478
DEVICE NAME: Organic Essentials
INDICATIONS FOR USE: Organic Cotton Tampon

Organic Essentials Organically
XGrown Coton Tampon is a tampon
that is inserted into the vagina and
used to absorb menstrual
fluid.

The intended use of the organic
cotton tampon is the same as
all other products that are
legally marketed.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation

Liliau Yi
(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Division of Reploadictive, Abdoming, ENThe - Counter and Radiological Dev (Optional Forma (k) Number

DK-55