SURGICAL GOWN, SMS


Device Classification Name

gown, surgical

510(k) Number K121152
Device Name SURGICAL GOWN, SMS
Applicant
JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD
7305 hancock village dr
suite 109
chesterfield, 
VA 
23832

Applicant Contact darren reeves
Correspondent
JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD
7305 hancock village dr
suite 109
chesterfield, 
VA 
23832

Correspodent Contact darren reeves
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 04/16/2012
Decision Date 12/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No