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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable, Reprocessed
510(k) Number K070930
Device Name REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
Applicant
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Applicant Contact DENNIS TOUSSAINT
Correspondent
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Correspondent Contact DENNIS TOUSSAINT
Regulation Number878.4750
Classification Product Code
NLL  
Date Received04/03/2007
Decision Date 10/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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