JIE+HONG MEDICAL SURGICAL GOWNS – STERILE, JIE+HONG MEDICAL SURGICAL GOWNS – NON STERILE


Device Classification Name

gown, surgical

510(k) Number K111067
Device Name JIE+HONG MEDICAL SURGICAL GOWNS – STERILE, JIE+HONG MEDICAL SURGICAL GOWNS – NON STERILE
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 878.4040
Classification Product Code
FYA  
Date Received 04/18/2011
Decision Date 08/02/2011
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