VIPON TAMPON

K992493 · Another Way Products, LLC · HEB · Nov 6, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K992493
• Device Name: VIPON TAMPON
• Applicant: Another Way Products, LLC
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Nov 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The Vipon tampon is indicated for females to absorb menstrual fluid and/or other vaginal discharge.

Device Story

Vipon menstrual tampon with applicator; designed for absorption of menstrual fluid and vaginal discharge. Device used by female patients for personal hygiene. Operates as a passive absorbent material inserted into the vaginal canal. No electronic, mechanical, or software components.

Technological Characteristics

Absorbent menstrual tampon with applicator. No electronic, software, or complex mechanical components.

Indications for Use

Indicated for females to absorb menstrual fluid and/or other vaginal discharge.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

6 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re:

K992493 Vipon™ Menstrual Tampon, with applicator Regulatory Class: II 21 CFR §884.5470/Procode: 85 HEB Dated: September 8, 2000 Received: September 11, 2000

Mr. Steven A. Kilgore Chief Executive Officer AnotherWay Products, L.L.C. c/o Mr. Gerard D. Eftink Van Hooser, Olsen, & Eftink, P.C. 704 W. Foxwood Drive P.O. Box 1280 RAYMORE MO 64083-1280

Dear Mr. Eftink:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desiness We have reviewed your Section 310(x) nother of mone stated in the enclosure) to legally marketed brecicale devices device is substantially equivalent (ur the multations for use at the Medical Device Amendments, or to devices Amendments, or to devices of to detice Art (Act Act Act (Act Act marketed in interstate commerce provisions of the Federal Food, Drug, and Comment Act (Act, You may, that have been reclassified in accordates with the provisions of the Act. The genral controls of the Act include therefore, market the device, subject to the gelleral confrolls of the reast and growth and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval); in the Code of Federal Regulations If your device is classified (see above) nine ellier class in (openin Control in the Code of Federal Regulations, to such additional controls. Existing major regulations are miliation with the Current Good Manufacturing Parts Party Parts Title 21, Parts 800 to 895. A substantialion (QS) for Medical Devices: General regulation (21 CFR Pat Practice requirements, as set form in the Quanty Dysterial (FDA) will verify such assumption . Failure 820) and that through periodic QS inspections, the room and Prag Transmission of Statisfaction submission does to comply with the GMP regulation may result in regulation in premarket notification sumission does not concerning your device in the Federal Regisel. Trease note: and response to your production of 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 \$10(k) premarke notification for your device and This letter will allow you to begally marketed predicated in your beging 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), please contact the Office of If you desire specific advice for your device on our labertising of your device, of your device ontact the Office of Compliance at [phone]. Also, please not the regulation entitled, "Misbranding by reference to premarke Office of Colliptalice at (501) 594-457. Filse, promotion on your responsibilities under the Att may be obtained from the notition of Small Manufacturers Assistance at is toll-free number [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K992493 |
|---------------------------|---------|
| Device Name: | VIPON |

Indications For Use:

The Vipon tampon is indicated for females to absorb menstrual fluid and/or other vaginal discharge.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use_

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(Optional Formal 3-10-98)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.