ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN


Device Classification Name

gown, surgical

510(k) Number K080795
Device Name ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
Applicant
KIMBERLY-CLARK CORP.
1400 holcomb bridge rd.
bldg 300, #1092
roswell, 
GA 
30076 -2199

Applicant Contact david m lee
Correspondent
KIMBERLY-CLARK CORP.
1400 holcomb bridge rd.
bldg 300, #1092
roswell, 
GA 
30076 -2199

Correspodent Contact david m lee
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 03/20/2008
Decision Date 09/03/2008
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