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510(k) K875147

TORQUE HEX WRENCH by Cardiac Pacemakers, Inc. — Product Code DTF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1988
Date Received
December 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tools, Pacemaker Service
Device Class
Class I
Regulation Number
870.3730
Review Panel
CV
Submission Type

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Other clearances for product code DTF

  • K781179 — WRENCH, GEXAGON, DRIVER (July 27, 1978)