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510(k) K924277

DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING by Chalgren Enterprises, Inc. — Product Code HLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1994
Date Received
August 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Preamplifier, Ac-Powered, Ophthalmic
Device Class
Class II
Regulation Number
886.1640
Review Panel
OP
Submission Type

Other clearances by Chalgren Enterprises, Inc.

  • K982950 — FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-55 (June 22, 1999)
  • K960591 — RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-X (June 13, 1996)
  • K955335 — DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE (January 29, 1996)
  • K953361 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K953356 — EMG RECORDING RING ELECTRODE (January 22, 1996)
  • K953354 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K952690 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K952908 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K953887 — RE-USABLE CONCENTRIC NEEDLE (October 31, 1995)
  • K953886 — RE-USABLE MONOPOLAR NEEDLE (October 31, 1995)

Other clearances for product code HLT

  • K921815 — TOMEY PE-300 PORTABLE ERG (July 15, 1992)
  • K841293 — PANORAMIC LOUPES - VARIOUS (May 9, 1984)
  • K781543 — ORBIOGRAPH (October 24, 1978)