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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K051291
Device Name NON-STERILE SURGICAL MASK
Applicant
A.R. MEDICOM, INC.
1200 55TH AVE.
LACHINE, QUEBEC,  CA H8T 3J8
Applicant Contact LUC TREPANIER
Correspondent
A.R. MEDICOM, INC.
1200 55TH AVE.
LACHINE, QUEBEC,  CA H8T 3J8
Correspondent Contact LUC TREPANIER
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/18/2005
Decision Date 09/20/2005
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
Recalls CDRH Recalls
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