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FDA 510(k)

LENS, HARD RESIN

K-Number: K772221 · 1978-01-30

ApplicantBorani Intl.
Decision Date1978-01-30
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENS, HARD RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Borani Intl.. It received FDA 510(k) clearance on 1978-01-30 under 510(k) number K772221. The device is classified under product code HQG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LENS, HARD RESIN?

LENS, HARD RESIN is a medical device that received FDA 510(k) clearance on 1978-01-30. The listed applicant is Borani Intl.. The 510(k) number is K772221.

When did LENS, HARD RESIN receive FDA 510(k) clearance?

LENS, HARD RESIN received FDA 510(k) clearance on 1978-01-30, under 510(k) number K772221.

Who is the listed applicant for LENS, HARD RESIN?

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

What is the FDA product code for LENS, HARD RESIN?

The FDA product code for LENS, HARD RESIN is HQG.

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Related Devices (Code: HQG)

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.

K935919SUNGLASSESJa-Ru, Inc.K9207950R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEXOptical Radiation Corp.K900091MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOROnufryk Low Vision Ent.K884360SEIKO P-6 PROGRESSIVE SPECTACLE LENSESSeiko Corp.K882814NEOLENS PRESCRIPTION SPECTACLE LENSNeolens, Inc.K882308CR-39 PLASTIC LENSES FOR EYEGLASSESAutomated Lens System

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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