KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS


Device Classification Name

mask, surgical

510(k) Number K110455
Device Name KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
Applicant
KIMBERLY-CLARK CORP.
1400 holcomb bridge rd.
roswell, 
GA 
30076

Applicant Contact ann waterhouse
Regulation Number 878.4040
Classification Product Code
FXX  
Date Received 02/15/2011
Decision Date 04/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party Yes

Combination Product

No