FDA 510(k) Application Details - K053585

Device Classification Name	Laparoscope, General & Plastic Surgery, Reprocessed   More FDA Info for this Device
510(K) Number	K053585
Device Name	Laparoscope, General & Plastic Surgery, Reprocessed
Applicant	ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. PHOENIX, AZ 85044 US Other 510(k) Applications for this Company
Contact	MOIRA BARTON 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	12/23/2005
Decision Date	10/11/2006
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