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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 K121240
Device Name REPROCESSED ENDOSCOPIC TROCARS
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Applicant Contact JASON SKRAMSTED, RAC
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Correspondent Contact JASON SKRAMSTED, RAC
Regulation Number876.1500
Classification Product Code
NLM  
Date Received04/24/2012
Decision Date 06/11/2012
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
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