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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
Contact jason skramsted, rac
Regulation Number876.1500
Classification Product Code
NLM  
Date Received04/24/2012
Decision Date 06/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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