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510(k) K841294

ACU220 CRYO UNIT by Keller Instruments, Inc. — Product Code HQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1984
Date Received
March 29, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryotherapy, Ophthalmic
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

Other clearances by Keller Instruments, Inc.

  • K854541 — TIP OFF FORCEPS (December 17, 1985)
  • K841293 — PANORAMIC LOUPES - VARIOUS (May 9, 1984)
  • K841292 — SPECTACLE INDIRECT OPHTHALMOSCOPE (May 9, 1984)
  • K823835 — SPEMBLY 140 CRYOSYSTEM PROBES & TIPS (January 17, 1983)

Other clearances for product code HQA

  • K854411 — KEELER-COMPACT CRYO SYSTEM (December 30, 1985)
  • K854422 — SERIES 25 SLIMLINE CRYO PROBES (December 30, 1985)
  • K823835 — SPEMBLY 140 CRYOSYSTEM PROBES & TIPS (January 17, 1983)