LRR — First Aid Kit With Drug Class N
Classification Details
- Product Code
- LRR
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
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 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K964029 | baxter healthcare | EMERGENCY RELIEF KIT SYSTEM | March 17, 1997 |
| K952561 | water-jel technologies | WATER JEL BURN KIT | July 14, 1995 |
| K940249 | certified safety mfg | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | October 3, 1994 |
| K941311 | certified safety mfg | FIRST AID/TRUMA KIT | June 14, 1994 |
| K931058 | mind mechanics | TICK-ATTACK(TM) KIT | March 1, 1994 |
| K931634 | polymint industrial co. | VARIOUS KITS | November 30, 1993 |
| K921762 | absentee shawnee bandage group | SHAWNEE PRODUCTS KIT I | January 6, 1993 |
| K903393 | hisler-radke | AUTO FIRST-AID KIT FOR AMERICA | January 31, 1991 |
| K896413 | james alexander | COMBINATION 6X-MAGNIFIER AND TWEEZERS | February 1, 1990 |
| K895767 | tick kit | ORIGINAL TICK KIT/1ST AID KIT | December 22, 1989 |
| K891483 | elwyn | FIRST AID SURVIVAL KIT | May 11, 1989 |
| K871376 | fraass survival systems | FIRST AID KIT, VARIOUS SIZES | June 4, 1987 |
| K871501 | fraass survival systems | KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE | June 2, 1987 |
| K871457 | fraass survival systems | FIRST AID KIT, EYE DRESSING | May 29, 1987 |
| K841900 | reed products | FIRST RESPONSE EMERG. EYE INJURIES | July 23, 1984 |