DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR


Device Classification Name

mask, surgical

510(k) Number K021546
Device Name DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
Original Applicant
CREATIVE CONTRACT (M) SDN BHD
8220 charles page blvd.
sand springs, 
OK 
74063

Original Contact mark reiber
Regulation Number 878.4040
Classification Product Code
FXX  
Date Received 05/10/2002
Decision Date 03/05/2003
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