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510(k) K971677

ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD by Transamerican Technologies Intl. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1997
Date Received
May 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Transamerican Technologies Intl.

  • K963193 — ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 (November 13, 1996)
  • K934398 — ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE (February 14, 1994)
  • K864378 — CO2 LASER MICROMANIPULATOR (March 5, 1987)

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