CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER— 510(k) K112093

Name: FDA 510(k) clearance K112093
Creator: U.S. Food and Drug Administration
Published: 2011-12-08

Substantially Equivalent

Keeler Instruments, Inc.

FDA 510(k) clearance K112093 for CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER, Substantially Equivalent on 2011-12-08. Applicant: Keeler Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Keeler Instruments, Inc.
Product code: Code HRN
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 2011-07-22
Decision date: 2011-12-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Broomall, PA, US

Download summary PDF View on FDA.gov ↗

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