Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SUN/SPORTGLASSES

K-Number: K920211 · 1992-05-01

Decision Date1992-05-01
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUN/SPORTGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Bacou USA, Inc. and Uvex Safety, Inc.. It received FDA 510(k) clearance on 1992-05-01 under 510(k) number K920211. 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 SUN/SPORTGLASSES?

SUN/SPORTGLASSES is a medical device that received FDA 510(k) clearance on 1992-05-01. The listed applicant is Bacou USA, Inc. and Uvex Safety, Inc.. The 510(k) number is K920211.

When did SUN/SPORTGLASSES receive FDA 510(k) clearance?

SUN/SPORTGLASSES received FDA 510(k) clearance on 1992-05-01, under 510(k) number K920211.

Who is the listed applicant for SUN/SPORTGLASSES?

The FDA 510(k) record lists Bacou USA, Inc. and Uvex Safety, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUN/SPORTGLASSES?

The FDA product code for SUN/SPORTGLASSES 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.

Other records listing Bacou USA, Inc. and Uvex Safety, Inc. as applicant

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

View on FDA Database →

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

↑