COBES SURGICAL DRAPE


Device Classification Name

drape, surgical

510(k) Number K112378
Device Name COBES SURGICAL DRAPE
Applicant
COBES INDUSTRIES CO., LTD.
3500 south dupont highway
dover, 
DE 
19901

Applicant Contact leon lu
Correspondent
COBES INDUSTRIES CO., LTD.
3500 south dupont highway
dover, 
DE 
19901

Correspodent Contact leon lu
Regulation Number 878.4370
Classification Product Code
KKX  
Date Received 08/18/2011
Decision Date 05/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No