SPEMBLY 140 CRYOSYSTEM PROBES & TIPS— 510(k) K823835

Name: FDA 510(k) clearance K823835
Creator: U.S. Food and Drug Administration
Published: 1983-01-17

Substantially Equivalent

Keller Instruments, Inc.

FDA 510(k) clearance K823835 for SPEMBLY 140 CRYOSYSTEM PROBES & TIPS, Substantially Equivalent on 1983-01-17. Applicant: Keller Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Keller Instruments, Inc.
Product code: Code HQA
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 1982-12-21
Decision date: 1983-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQA

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K854411 — KEELER-COMPACT CRYO SYSTEM1985-12-30
K854422 — SERIES 25 SLIMLINE CRYO PROBES1985-12-30
K841294 — ACU220 CRYO UNIT1984-08-15

More clearances from Keller Instruments, Inc.

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K854541 — TIP OFF FORCEPS1985-12-17
K841292 — SPECTACLE INDIRECT OPHTHALMOSCOPE1984-05-09
K841293 — PANORAMIC LOUPES - VARIOUS1984-05-09

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