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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 K172093
Device Name Reprocessed Covidien Trocar
Applicant
Renovo, Inc.
340 SW Columbia St.
Bend,  OR  97702
Applicant Contact Mark K. Wells
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Robert V. Packard
Regulation Number876.1500
Classification Product Code
NLM  
Date Received07/11/2017
Decision Date 10/05/2017
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
Predetermined Change
Control Plan Authorized		 No
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