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510(k) K925708

DISPOSABLE ELECTROSURGERY BALL ELECTRODE by Beacon Laboratories, Inc. — Product Code DWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
November 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical Device
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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  • K915788 — MIS ELECTROSURGICAL ELECTRODES (March 13, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K913772 — PRESSURE GUARD (November 19, 1991)
  • K905752 — ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE (July 22, 1991)
  • K904506 — ACTIVE ADAPTER (December 13, 1990)
  • K902996 — ARGON BEAM LAPAROSCOPIC ELECTRODE (November 21, 1990)

Other clearances for product code DWG

  • K942823 — MAHE INSTRUMENTS (December 5, 1994)
  • K932345 — TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE (April 12, 1994)
  • K931215 — HAND-TROL S (March 28, 1994)