FDA 510(k) Application Details - K983200

Device Classification Name	Needle, Aspiration And Injection, Disposable   More FDA Info for this Device
510(K) Number	K983200
Device Name	Needle, Aspiration And Injection, Disposable
Applicant	XIMED/PROSURE/INJECTX 2195 TRADE ZONE BLVD. SAN JOSE, CA 95131 US Other 510(k) Applications for this Company
Contact	ASHVIN DESAI Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	GAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/1998
Decision Date	12/11/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review