SRI PLR GOWN


Device Classification Name

gown, surgical

510(k) Number K080707
Device Name SRI PLR GOWN
Applicant
SRI/SURGICAL EXPRESS
p.o. box 92493
austin, 
TX 
78709

Applicant Contact jeffrey o stull
Correspondent
SRI/SURGICAL EXPRESS
p.o. box 92493
austin, 
TX 
78709

Correspodent Contact jeffrey o stull
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 03/12/2008
Decision Date 11/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No