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510(k) K945861

BERGEN 710 ESU by Bergen Mfg. — Product Code HAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1995
Date Received
December 1, 1994
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

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  • K881334 — LIGHT COAGULATOR LC 250 (November 16, 1989)
  • K894762 — B100 DISPOSABLE HANDPIECE (September 15, 1989)
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