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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K070428
Device Name MEDICOM SELF-SEALING STERILIZATION POUCH
Applicant
A.R. Medicom, Inc.
1200 55th Ave.
Lachine (Montreal),  CA H 8T 3J8
Applicant Contact JASON LUDVIG
Correspondent
A.R. Medicom, Inc.
1200 55th Ave.
Lachine (Montreal),  CA H 8T 3J8
Correspondent Contact JASON LUDVIG
Regulation Number880.6850
Classification Product Code
KCT  
Date Received02/13/2007
Decision Date 07/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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