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510(k) K951369

EDM by Deltex Medical — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1995
Date Received
March 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

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