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510(k) K781179

WRENCH, GEXAGON, DRIVER by Telectronics, Inc. — Product Code DTF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
July 14, 1978
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

Other clearances by Telectronics, Inc.

  • K890895 — IMPLANTABLE ADAPTOR 033-380 (March 6, 1990)
  • K891231 — OPTIMA MPT AND SPT PACEMAKERS (September 12, 1989)
  • K890350 — VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) (February 2, 1989)
  • K884411 — OPTIMA MPT AND SPT PACEMAKERS (January 26, 1989)
  • K884278 — IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 (December 15, 1988)
  • K881837 — OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D (July 18, 1988)
  • K874664 — IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 (May 31, 1988)
  • K864712 — MODEL 1740 PERSONAL POCKET PROGRAMMER (December 17, 1987)
  • K872766 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (November 4, 1987)
  • K865098 — SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 (August 18, 1987)

Other clearances for product code DTF

  • K875147 — TORQUE HEX WRENCH (January 27, 1988)