FDA 510(k) Application Details - K001339

Device Classification Name	Retractor   More FDA Info for this Device
510(K) Number	K001339
Device Name	Retractor
Applicant	OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 1100 NEW BRIGHTON BLVD. MINNEAPOLIS, MN 55413-1660 US Other 510(k) Applications for this Company
Contact	CATHERINE MILLER Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	GAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2000
Decision Date	05/17/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review