KIMGUARD SMART-FOLD* STERILIZATION WRAP


Device Classification Name

wrap, sterilization

510(k) Number K112300
Device Name KIMGUARD SMART-FOLD* STERILIZATION WRAP
Applicant
KIMBERLY-CLARK CORP.
1400 holcomb bridge rd.
bldg 300
roswell, 
GA 
30076 -2199

Applicant Contact brenda shelkey
Correspondent
KIMBERLY-CLARK CORP.
1400 holcomb bridge rd.
bldg 300
roswell, 
GA 
30076 -2199

Correspodent Contact brenda shelkey
Regulation Number 880.6850
Classification Product Code
FRG  
Date Received 08/10/2011
Decision Date 01/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No