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510(k) K182905

UniPulse by Seaward Group — Product Code DRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2018
Date Received
October 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Defibrillator
Device Class
Class II
Regulation Number
870.5325
Review Panel
CV
Submission Type

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