LRR — First Aid Kit With Drug Class N

FDA Device Classification

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-NumberApplicantDevice NameDate
K964029baxter healthcareEMERGENCY RELIEF KIT SYSTEMMarch 17, 1997
K952561water-jel technologiesWATER JEL BURN KITJuly 14, 1995
K940249certified safety mfgCERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSINGOctober 3, 1994
K941311certified safety mfgFIRST AID/TRUMA KITJune 14, 1994
K931058mind mechanicsTICK-ATTACK(TM) KITMarch 1, 1994
K931634polymint industrial co.VARIOUS KITSNovember 30, 1993
K921762absentee shawnee bandage groupSHAWNEE PRODUCTS KIT IJanuary 6, 1993
K903393hisler-radkeAUTO FIRST-AID KIT FOR AMERICAJanuary 31, 1991
K896413james alexanderCOMBINATION 6X-MAGNIFIER AND TWEEZERSFebruary 1, 1990
K895767tick kitORIGINAL TICK KIT/1ST AID KITDecember 22, 1989
K891483elwynFIRST AID SURVIVAL KITMay 11, 1989
K871376fraass survival systemsFIRST AID KIT, VARIOUS SIZESJune 4, 1987
K871501fraass survival systemsKIT, FIRST AID, GENERAL PURPOSE, RIGID CASEJune 2, 1987
K871457fraass survival systemsFIRST AID KIT, EYE DRESSINGMay 29, 1987
K841900reed productsFIRST RESPONSE EMERG. EYE INJURIESJuly 23, 1984