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510(k) K884522

MODEL 5650 OPTIMATE PERSONAL PROGRAMMER by Teletronics, Inc. — Product Code KRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1989
Date Received
October 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Pacemaker
Device Class
Class III
Regulation Number
870.3700
Review Panel
CV
Submission Type

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