PRE-OPERATIVE OPHTHALMIC DRESSING TRAY— 510(k) K842601

Name: FDA 510(k) clearance K842601
Creator: U.S. Food and Drug Administration
Published: 1985-05-10

Substantially Equivalent

Ophthalmic Resources, Inc.

FDA 510(k) clearance K842601 for PRE-OPERATIVE OPHTHALMIC DRESSING TRAY, Substantially Equivalent on 1985-05-10. Applicant: Ophthalmic Resources, Inc.. Device class: 2.

Clearance details

Applicant: Ophthalmic Resources, Inc.
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 1984-07-05
Decision date: 1985-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

Download summary PDF View on FDA.gov ↗

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