GALLIE CRYONUCLEATOR— 510(k) K833747

Name: FDA 510(k) clearance K833747
Creator: U.S. Food and Drug Administration
Published: 1984-05-09

Substantially Equivalent

Mono Research Laboratories

FDA 510(k) clearance K833747 for GALLIE CRYONUCLEATOR, Substantially Equivalent on 1984-05-09. Applicant: Mono Research Laboratories. Device class: 2.

Clearance details

Applicant: Mono Research Laboratories
Product code: Code HPS
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 1983-10-26
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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