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510(k) K000079

NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M by Nikomed U.S.A., Inc. — Product Code HAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2000
Date Received
January 11, 2000
Clearance Type
Special
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 Nikomed U.S.A., Inc.

  • K022909 — NIKOMED TRACE 1 ECG ELECTRODES (January 9, 2003)
  • K950473 — DISPOSABLE ECG MONITORING ELECTRODE (December 12, 1995)
  • K950472 — DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM (November 14, 1995)
  • K950475 — DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 (November 14, 1995)
  • K950480 — DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM (November 6, 1995)
  • K950478 — DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM (November 6, 1995)
  • K950470 — DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM (November 6, 1995)
  • K950471 — DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM (November 6, 1995)
  • K950474 — DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM (November 6, 1995)
  • K950477 — DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM (November 6, 1995)

Other clearances for product code HAM

  • K153472 — Quiver Laparoscopic Extendable (June 23, 2016)
  • 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)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)
  • K894762 — B100 DISPOSABLE HANDPIECE (September 15, 1989)