WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD


Device Classification Name

mask, surgical

510(k) Number K023755
Device Name WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD
Original Applicant
WINNER INDUSTRIES (SHENZHEN) CO., LTD.
1900-h proforma ave.
ontario, 
CA 
92861

Original Contact ming xie
Regulation Number 878.4040
Classification Product Code
FXX  
Date Received 11/08/2002
Decision Date 06/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No