TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE


Device Classification Name

drape, surgical

510(k) Number K112136
Device Name TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
Applicant
KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.
1340 west pennsylvania ave
san diego, 
CA 
92103

Applicant Contact glen feye
Correspondent
KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.
1340 west pennsylvania ave
san diego, 
CA 
92103

Correspodent Contact glen feye
Regulation Number 878.4370
Classification Product Code
KKX  
Date Received 07/26/2011
Decision Date 09/29/2011
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