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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 (Montreal),  CA H 8T 3J8
Applicant Contact LUC TREPANIER
Correspondent
A.R. Medicom, Inc.
1200 55th Ave.
Lachine (Montreal),  CA H 8T 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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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