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FDA 510(k)

EYE COOLER

K-Number: K946231 · 1995-01-17

ApplicantDirect Import Marketing Co.
Decision Date1995-01-17
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE COOLER is the device name listed in this FDA 510(k) record. The listed applicant is Direct Import Marketing Co.. It received FDA 510(k) clearance on 1995-01-17 under 510(k) number K946231. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE COOLER?

EYE COOLER is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Direct Import Marketing Co.. The 510(k) number is K946231.

When did EYE COOLER receive FDA 510(k) clearance?

EYE COOLER received FDA 510(k) clearance on 1995-01-17, under 510(k) number K946231.

Who is the listed applicant for EYE COOLER?

The FDA 510(k) record lists Direct Import Marketing Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYE COOLER?

The FDA product code for EYE COOLER is HQY.

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Related Devices (Code: HQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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