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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery, Reprocessed
510(k) Number K133414
Device Name REPROCESSED CLOSURE SYSTEM
Applicant
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Applicant Contact JASON SKRAMSTED
Correspondent
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Correspondent Contact JASON SKRAMSTED
Regulation Number876.1500
Classification Product Code
NLM  
Subsequent Product Codes
GCJ   GEJ   HCF  
Date Received11/07/2013
Decision Date 01/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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