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FDA 510(k)

PRIMARY MANUFACTURER SUNGLASSES

K-Number: K903065 · 1991-02-13

ApplicantMao Lin Ent.
Decision Date1991-02-13
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PRIMARY MANUFACTURER SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Mao Lin Ent.. It received FDA 510(k) clearance on 1991-02-13 under 510(k) number K903065. 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 PRIMARY MANUFACTURER SUNGLASSES?

PRIMARY MANUFACTURER SUNGLASSES is a medical device that received FDA 510(k) clearance on 1991-02-13. The listed applicant is Mao Lin Ent.. The 510(k) number is K903065.

When did PRIMARY MANUFACTURER SUNGLASSES receive FDA 510(k) clearance?

PRIMARY MANUFACTURER SUNGLASSES received FDA 510(k) clearance on 1991-02-13, under 510(k) number K903065.

Who is the listed applicant for PRIMARY MANUFACTURER SUNGLASSES?

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

What is the FDA product code for PRIMARY MANUFACTURER SUNGLASSES?

The FDA product code for PRIMARY MANUFACTURER SUNGLASSES 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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