WINK-EASE DISPOSABLE PROTECTIVE— 510(k) K860043

Name: FDA 510(k) clearance K860043
Creator: U.S. Food and Drug Administration
Published: 1986-02-07

Substantially Equivalent

Eye Pro Medical Products, Inc.

FDA 510(k) clearance K860043 for WINK-EASE DISPOSABLE PROTECTIVE, Substantially Equivalent on 1986-02-07. Applicant: Eye Pro Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Eye Pro Medical Products, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1986-01-06
Decision date: 1986-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Wayne, IN, US

Download summary PDF View on FDA.gov ↗

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