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510(k) K800376

EPR-200 PROGRAMMER MODEL 010 by Biotronik Sales, Inc. — Product Code KRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1980
Date Received
February 21, 1980
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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