FDA 510(k) Application Details - K954284

Device Classification Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K954284
Device Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant	MEDI-PLAST INTL., INC. 55 NORTHERN BLVD. SUITE 410 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	CAROLANN KOTULA Other 510(k) Applications for this Contact
Regulation Number	870.4290   More FDA Info for this Regulation Number
Classification Product Code	DTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/1995
Decision Date	02/12/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review