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FDA 510(k)

MULTIPLE LENS, SPECTACLES CUSTOM

K-Number: K842189 · 1984-12-11

ApplicantHanmy Optical Industrial Co.
Decision Date1984-12-11
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MULTIPLE LENS, SPECTACLES CUSTOM is the device name listed in this FDA 510(k) record. The listed applicant is Hanmy Optical Industrial Co.. It received FDA 510(k) clearance on 1984-12-11 under 510(k) number K842189. 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 MULTIPLE LENS, SPECTACLES CUSTOM?

MULTIPLE LENS, SPECTACLES CUSTOM is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Hanmy Optical Industrial Co.. The 510(k) number is K842189.

When did MULTIPLE LENS, SPECTACLES CUSTOM receive FDA 510(k) clearance?

MULTIPLE LENS, SPECTACLES CUSTOM received FDA 510(k) clearance on 1984-12-11, under 510(k) number K842189.

Who is the listed applicant for MULTIPLE LENS, SPECTACLES CUSTOM?

The FDA 510(k) record lists Hanmy Optical Industrial Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPLE LENS, SPECTACLES CUSTOM?

The FDA product code for MULTIPLE LENS, SPECTACLES CUSTOM 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

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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