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510(k) K894663

BEAMER ONE by Beacon Laboratories, Inc. — Product Code HAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1989
Date Received
July 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Beacon Laboratories, Inc.

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  • K922289 — SESQUIPOLAR(TM) MIS ELECTRODE (January 15, 1993)
  • K925619 — DISPOSABLE HAND-SWITCHING ESU PENCIL (December 24, 1992)
  • 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)

Other clearances for product code HAM

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  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K945861 — BERGEN 710 ESU (March 1, 1995)
  • K913300 — LAPAROSTAT(TM) (April 2, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K911353 — EMC MODEL NO. STATOME 900 (June 24, 1991)
  • K901248 — ABC HANDPIECE ADAPTER (April 3, 1990)
  • K881334 — LIGHT COAGULATOR LC 250 (November 16, 1989)
  • K894762 — B100 DISPOSABLE HANDPIECE (September 15, 1989)