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FDA 510(k) Application Details - K172093
Device Classification Name
Laparoscope, General & Plastic Surgery, Reprocessed
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510(K) Number
K172093
Device Name
Laparoscope, General & Plastic Surgery, Reprocessed
Applicant
Renovo, Inc.
340 SW Columbia St.
Bend, OR 97702 US
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Contact
Mark K. Wells
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
NLM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/11/2017
Decision Date
10/05/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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