FDA 510(k) Application Details - K972918

Device Classification Name	Stylet, Surgical, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K972918
Device Name	Stylet, Surgical, General & Plastic Surgery
Applicant	APEX MEDICAL PRODUCTS, LLC. 9109 COPENHAVER DR. POTOMAC, MD 20854 US Other 510(k) Applications for this Company
Contact	NORMAN R ESTRIN Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	GAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/1997
Decision Date	10/27/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review