EYE COOLER— 510(k) K946231

Substantially Equivalent

Direct Import Marketing Co.

FDA 510(k) clearance K946231 for EYE COOLER, Substantially Equivalent on 1995-01-17. Applicant: Direct Import Marketing Co.. Device class: 1.

Clearance details

Applicant: Direct Import Marketing Co.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-12-22
Decision date: 1995-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

K974852 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974860 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974861 — NON-PRESCRIPTION SUNGLASSES1998-01-27
K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

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