FDA 510(k) Application Details - K062497

Device Classification Name	Laparoscope, General & Plastic Surgery, Reprocessed   More FDA Info for this Device
510(K) Number	K062497
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	ELIZABETH RENKIN 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	08/25/2006
Decision Date	01/31/2007
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