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FDA 510(k)

UVEX MINI-SPECS

K-Number: K813548 · 1982-03-02

ApplicantBacou USA, Inc. and Uvex Safety, Inc.
Decision Date1982-03-02
Product CodeHOI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UVEX MINI-SPECS 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 1982-03-02 under 510(k) number K813548. The device is classified under product code HOI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UVEX MINI-SPECS?

UVEX MINI-SPECS is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is Bacou USA, Inc. and Uvex Safety, Inc.. The 510(k) number is K813548.

When did UVEX MINI-SPECS receive FDA 510(k) clearance?

UVEX MINI-SPECS received FDA 510(k) clearance on 1982-03-02, under 510(k) number K813548.

Who is the listed applicant for UVEX MINI-SPECS?

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 MINI-SPECS?

The FDA product code for UVEX MINI-SPECS is HOI.

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/SPORTGLASSESK820016UVEX ALPHA, BETA, GAMMA & DELTA SUN

Related Devices (Code: HOI)

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.

K943613NILSing Wah International Enterprises , Ltd.K930435SPECTACLE FRAMESVenis DI A. VendrameK931328PYRAMID SUNGLASSES/PYRAMID READING GLASSESPyramidK910329SUNGLASSESCutler & Gross Sloan Optical , Ltd.K854854SYSTEMS OF SIGHT LOW VISION EYEWAREInt'L Eye Care, Inc.K844716MAGNIFYING SPECTACLES W/PLASTIC LENSESGazelle Corp.

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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