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FDA 510(k)

SPECTACLE FRAMES, SUNGLASSES

K-Number: K936125 · 1994-08-04

ApplicantEyedesigns Corp.
Decision Date1994-08-04
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE FRAMES, SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Eyedesigns Corp.. It received FDA 510(k) clearance on 1994-08-04 under 510(k) number K936125. 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 SPECTACLE FRAMES, SUNGLASSES?

SPECTACLE FRAMES, SUNGLASSES is a medical device that received FDA 510(k) clearance on 1994-08-04. The listed applicant is Eyedesigns Corp.. The 510(k) number is K936125.

When did SPECTACLE FRAMES, SUNGLASSES receive FDA 510(k) clearance?

SPECTACLE FRAMES, SUNGLASSES received FDA 510(k) clearance on 1994-08-04, under 510(k) number K936125.

Who is the listed applicant for SPECTACLE FRAMES, SUNGLASSES?

The FDA 510(k) record lists Eyedesigns Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTACLE FRAMES, SUNGLASSES?

The FDA product code for SPECTACLE FRAMES, SUNGLASSES 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

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

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