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510(k) K841293

PANORAMIC LOUPES - VARIOUS by Keller Instruments, Inc. — Product Code HLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
March 29, 1984
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 Keller Instruments, Inc.

  • K854541 — TIP OFF FORCEPS (December 17, 1985)
  • K841294 — ACU220 CRYO UNIT (August 15, 1984)
  • K841292 — SPECTACLE INDIRECT OPHTHALMOSCOPE (May 9, 1984)
  • K823835 — SPEMBLY 140 CRYOSYSTEM PROBES & TIPS (January 17, 1983)

Other clearances for product code HLT

  • K924277 — DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING (December 7, 1994)
  • K921815 — TOMEY PE-300 PORTABLE ERG (July 15, 1992)
  • K781543 — ORBIOGRAPH (October 24, 1978)