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510(k) K934067

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 by National Custom Ent., Inc. — Product Code DRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1993
Date Received
August 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, High Energy, (Including Paddles)
Device Class
Class III
Regulation Number
870.5300
Review Panel
CV
Submission Type

PMA to be filed by 12/26/96 (FR 50706 (9/27/96))

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