FDA 510(k) Application Details - K974158

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K974158
Device Name	Instrument, Biopsy
Applicant	ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH DRAPER, UT 84020 US Other 510(k) Applications for this Company
Contact	CAROL FRASIER 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	11/03/1997
Decision Date	12/09/1997
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