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510(k) K150041

CORA (Coagulation Resonance Analysis) System by Coramed Technologies, LLC — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2015
Date Received
January 9, 2015
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

Other clearances by Coramed Technologies, LLC

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