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..

Clearance details

Applicant
Cool Eyes, Inc.
Product code
Code HOY
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Harrow, Ontario, CA
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