FDA 510(k) Application Details - K960064

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K960064
Device Name	Instrument, Biopsy
Applicant	BAUER MEDICAL, INC. 13191 56TH COURT SUITE 106 CLEARWATER, FL 34620 US Other 510(k) Applications for this Company
Contact	PAT LAMB Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/1996
Decision Date	04/05/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review