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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 AVENUE NORTH
MAPLE GROVE,  MN  55369
Applicant Contact JASON SKRAMSTED
Correspondent
STERILMED, INC.
11400 73RD AVENUE NORTH
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 Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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