FDA 510(k) Application Details - K011586

Device Classification Name	Needle, Aspiration And Injection, Disposable   More FDA Info for this Device
510(K) Number	K011586
Device Name	Needle, Aspiration And Injection, Disposable
Applicant	DIAMETRICS MEDICAL, INC. 2658 PATTON RD. SAINT PAUL, MN 55113 US Other 510(k) Applications for this Company
Contact	NANCY RING 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	05/23/2001
Decision Date	11/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review