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FDA 510(k)

SPECTACLE FRAMES (NON-PRESCRIPTION)

K-Number: K972246 · 1997-06-26

Decision Date1997-06-26
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE FRAMES (NON-PRESCRIPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Alimar Trading, Inc.. It received FDA 510(k) clearance on 1997-06-26 under 510(k) number K972246. 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 (NON-PRESCRIPTION)?

SPECTACLE FRAMES (NON-PRESCRIPTION) is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is Alimar Trading, Inc.. The 510(k) number is K972246.

When did SPECTACLE FRAMES (NON-PRESCRIPTION) receive FDA 510(k) clearance?

SPECTACLE FRAMES (NON-PRESCRIPTION) received FDA 510(k) clearance on 1997-06-26, under 510(k) number K972246.

Who is the listed applicant for SPECTACLE FRAMES (NON-PRESCRIPTION)?

The FDA 510(k) record lists Alimar Trading, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTACLE FRAMES (NON-PRESCRIPTION)?

The FDA product code for SPECTACLE FRAMES (NON-PRESCRIPTION) is HQY.

Related Clinical Trials

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.

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.

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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