COOL EYE(TM) EYE PROTECTOR— 510(k) K881135

Substantially Equivalent

Cool Eyes, Inc.

FDA 510(k) clearance K881135 for COOL EYE(TM) EYE PROTECTOR, Substantially Equivalent on 1988-07-08. Applicant: Cool Eyes, Inc.. Device class: 1.

Clearance details

Applicant: Cool Eyes, Inc.
Product code: Code HOY
Device class: Class 1
Regulation: 21 CFR 886.4750
Advisory panel: Ophthalmic
Date received: 1988-03-16
Decision date: 1988-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harrow, Ontario, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.