FDA 510(k) Application Details - K153258

Device Classification Name	Laparoscope, General & Plastic Surgery, Reprocessed   More FDA Info for this Device
510(K) Number	K153258
Device Name	Laparoscope, General & Plastic Surgery, Reprocessed
Applicant	Surgical Instrument Service and Savings (dba Medline ReNewal 2747 SW 6th St. Redmond, OR 97756 US Other 510(k) Applications for this Company
Contact	Brandi J Panteleon Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	NLM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2015
Decision Date	04/05/2016
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