LRR · First Aid Kit With Drug
· Class N
Overview
| Product Code | LRR |
|---|---|
| Device Name | First Aid Kit With Drug |
| Device Class | Class N |
| Review Panel |
Identification
Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964029 | EMERGENCY RELIEF KIT SYSTEM | Baxter Healthcare Corp | Mar 17, 1997 | SEKD |
| K952561 | WATER JEL BURN KIT | Water-Jel Technologies, Inc. | Jul 14, 1995 | SESE |
| K940249 | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | Certified Safety Mfg., Inc. | Oct 3, 1994 | SEKD |
| K941311 | FIRST AID/TRUMA KIT | Certified Safety Mfg., Inc. | Jun 14, 1994 | SESE |
| K931058 | TICK-ATTACK(TM) KIT | Mind Mechanics, Inc. | Mar 1, 1994 | SESK |
| K931634 | VARIOUS KITS | Polymint Industrial Co. , Ltd. | Nov 30, 1993 | SEKD |
| K921762 | SHAWNEE PRODUCTS KIT I | Absentee Shawnee Bandage Group | Jan 6, 1993 | SEKD |
| K903393 | AUTO FIRST-AID KIT FOR AMERICA | Hisler-Radke, Inc. | Jan 31, 1991 | SESK |
| K896413 | COMBINATION 6X-MAGNIFIER AND TWEEZERS | James Alexander Corp. | Feb 1, 1990 | SESE |
| K895767 | ORIGINAL TICK KIT/1ST AID KIT | Tick Kit, Inc. | Dec 22, 1989 | SESD |
| K891483 | FIRST AID SURVIVAL KIT | Elwyn, Inc. | May 11, 1989 | SESE |
| K871376 | FIRST AID KIT, VARIOUS SIZES | Fraass Survival Systems, Inc. | Jun 4, 1987 | SESD |
| K871501 | KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE | Fraass Survival Systems, Inc. | Jun 2, 1987 | SESE |
| K871457 | FIRST AID KIT, EYE DRESSING | Fraass Survival Systems, Inc. | May 29, 1987 | SESD |
| K841900 | FIRST RESPONSE EMERG. EYE INJURIES | Reed Products, Inc. | Jul 23, 1984 | SESE |
Top Applicants
- Fraass Survival Systems, Inc. — 3 clearances
- Certified Safety Mfg., Inc. — 2 clearances
- Absentee Shawnee Bandage Group — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Elwyn, Inc. — 1 clearance
