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510(k) K123035

SEAL ONE by Perouse Medical — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2012
Date Received
September 28, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

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