SURGICAL MASKS


Device Classification Name

mask, surgical

510(k) Number K111559
Device Name SURGICAL MASKS
Applicant
SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Applicant Contact diana hong
Correspondent
SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Correspodent Contact diana hong
Regulation Number 878.4040
Classification Product Code
FXX  
Date Received 06/06/2011
Decision Date 09/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No