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510(k) K963579

PACE-1A CARDIAC STIMULATOR by Radionics, Inc. — Product Code JOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1996
Date Received
September 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Device Class
Class II
Regulation Number
870.1750
Review Panel
CV
Submission Type

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