FDA 510(k) Application Details - K971114

Device Classification Name	Needle, Aspiration And Injection, Reusable   More FDA Info for this Device
510(K) Number	K971114
Device Name	Needle, Aspiration And Injection, Reusable
Applicant	BIOACCESS, INC. 8400 CEDAR ST. SILVER SPRING, MD 20910 US Other 510(k) Applications for this Company
Contact	PETER J CARNES Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	GDM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/1997
Decision Date	06/03/1997
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