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FDA 510(k)

MAGNIFYING SPECTACLES W/PLASTIC LENSES

K-Number: K844716 · 1985-01-03

ApplicantGazelle Corp.
Decision Date1985-01-03
Product CodeHOI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAGNIFYING SPECTACLES W/PLASTIC LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Gazelle Corp.. It received FDA 510(k) clearance on 1985-01-03 under 510(k) number K844716. 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 MAGNIFYING SPECTACLES W/PLASTIC LENSES?

MAGNIFYING SPECTACLES W/PLASTIC LENSES is a medical device that received FDA 510(k) clearance on 1985-01-03. The listed applicant is Gazelle Corp.. The 510(k) number is K844716.

When did MAGNIFYING SPECTACLES W/PLASTIC LENSES receive FDA 510(k) clearance?

MAGNIFYING SPECTACLES W/PLASTIC LENSES received FDA 510(k) clearance on 1985-01-03, under 510(k) number K844716.

Who is the listed applicant for MAGNIFYING SPECTACLES W/PLASTIC LENSES?

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

What is the FDA product code for MAGNIFYING SPECTACLES W/PLASTIC LENSES?

The FDA product code for MAGNIFYING SPECTACLES W/PLASTIC LENSES 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 Gazelle Corp. 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.

K820375PLASTIC OR GLASS MAGNIFIER

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.K844038VISITEC MAGNIFYING SPECTACLESVisitec Co.

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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