510(k) K897196

ADVANCE STOPCOCKS ADVANCE MANIFOLDS by Advance Medical Designs, Inc. — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1990
Date Received
December 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
Review Panel
CV
Submission Type