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FDA 510(k)

UVEX ALPHA, BETA, GAMMA & DELTA SUN

K-Number: K820016 · 1982-03-19

ApplicantBacou USA, Inc. and Uvex Safety, Inc.
Decision Date1982-03-19
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UVEX ALPHA, BETA, GAMMA & DELTA SUN 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 1982-03-19 under 510(k) number K820016. 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 UVEX ALPHA, BETA, GAMMA & DELTA SUN?

UVEX ALPHA, BETA, GAMMA & DELTA SUN is a medical device that received FDA 510(k) clearance on 1982-03-19. The listed applicant is Bacou USA, Inc. and Uvex Safety, Inc.. The 510(k) number is K820016.

When did UVEX ALPHA, BETA, GAMMA & DELTA SUN receive FDA 510(k) clearance?

UVEX ALPHA, BETA, GAMMA & DELTA SUN received FDA 510(k) clearance on 1982-03-19, under 510(k) number K820016.

Who is the listed applicant for UVEX ALPHA, BETA, GAMMA & DELTA SUN?

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 UVEX ALPHA, BETA, GAMMA & DELTA SUN?

The FDA product code for UVEX ALPHA, BETA, GAMMA & DELTA SUN 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.

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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.

K920211SUN/SPORTGLASSESK813548UVEX MINI-SPECS

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

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.

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