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510(k) K853291

GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 by Bio-Detek, Inc. — Product Code HAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1985
Date Received
August 5, 1985
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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Other clearances for product code HAM

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  • 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)