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510(k) K083842

ROTEM DELTA THROMBOELASTOMETRY SYSTEM by Pentapharm GmbH — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2010
Date Received
December 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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