KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL


Device Classification Name

mask, surgical

510(k) Number K111402
Device Name KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
Applicant
KIMBERLY-CLARK
1400 holcomb bridge road
roswell, 
GA 
30076

Applicant Contact ann waterhouse, rac
Correspondent
KIMBERLY-CLARK
1400 holcomb bridge road
roswell, 
GA 
30076

Correspodent Contact ann waterhouse, rac
Regulation Number 878.4040
Classification Product Code
FXX  
Date Received 05/19/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No