OPHTHALMIC CRYO UNIT— 510(k) K940373

Name: FDA 510(k) clearance K940373
Creator: U.S. Food and Drug Administration
Published: 1994-07-18

Substantially Equivalent

Dutch Ophthalmic USA, Inc.

FDA 510(k) clearance K940373 for OPHTHALMIC CRYO UNIT, Substantially Equivalent on 1994-07-18. Applicant: Dutch Ophthalmic USA, Inc.. Device class: 2.

Clearance details

Applicant: Dutch Ophthalmic USA, Inc.
Product code: Code HPS
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 1994-01-26
Decision date: 1994-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, NH, US

Download summary PDF View on FDA.gov ↗

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