EYE IRRIGATOR MODEL #2020— 510(k) K980647

Name: FDA 510(k) clearance K980647
Creator: U.S. Food and Drug Administration
Published: 1998-05-15

Substantially Equivalent

Eye-Deal Ocular Safety Products, Inc.

FDA 510(k) clearance K980647 for EYE IRRIGATOR MODEL #2020, Substantially Equivalent on 1998-05-15. Applicant: Eye-Deal Ocular Safety Products, Inc.. Device class: 1.

Clearance details

Applicant: Eye-Deal Ocular Safety Products, Inc.
Product code: Code KYG
Device class: Class 1
Regulation: 21 CFR 886.4360
Advisory panel: Ophthalmic
Date received: 1998-02-17
Decision date: 1998-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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