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510(k) K093992

TERUMO LAUER LOCK ADAPTER by Terumo Cardiovascular Systems Corporation — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2010
Date Received
December 24, 2009
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

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