SRI LP DRAPE


Device Classification Name

drape, surgical

510(k) Number K080796
Device Name SRI LP DRAPE
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 878.4370
Classification Product Code
KKX  
Date Received 03/20/2008
Decision Date 11/17/2008
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