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510(k) K081359

GENESIS ECP by Scottcare Corporation — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2008
Date Received
May 15, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type

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