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FDA 510(k)

SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES

K-Number: K914473 · 1992-08-05

Decision Date1992-08-05
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Optics Co. of America, Inc.. It received FDA 510(k) clearance on 1992-08-05 under 510(k) number K914473. 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 SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES?

SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES is a medical device that received FDA 510(k) clearance on 1992-08-05. The listed applicant is Biomedical Optics Co. of America, Inc.. The 510(k) number is K914473.

When did SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES receive FDA 510(k) clearance?

SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES received FDA 510(k) clearance on 1992-08-05, under 510(k) number K914473.

Who is the listed applicant for SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES?

The FDA 510(k) record lists Biomedical Optics Co. of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES?

The FDA product code for SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 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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