SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE


Device Classification Name

drape, surgical

510(k) Number K081476
Device Name SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE
Applicant
SURGICAL CONCEPT DESIGNS
307 prospect avenue
suite 2g
hackensack, 
NJ 
07601

Applicant Contact christopher scott
Correspondent
SURGICAL CONCEPT DESIGNS
307 prospect avenue
suite 2g
hackensack, 
NJ 
07601

Correspodent Contact christopher scott
Regulation Number 878.4370
Classification Product Code
KKX  
Date Received 05/27/2008
Decision Date 08/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No