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FDA 510(k)

LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)

K-Number: K861162 · 1986-06-09

ApplicantEfop
Decision Date1986-06-09
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Efop. It received FDA 510(k) clearance on 1986-06-09 under 510(k) number K861162. 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 SPECTACLE NON-CUSTOM (PRESCRIPTION)?

LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) is a medical device that received FDA 510(k) clearance on 1986-06-09. The listed applicant is Efop. The 510(k) number is K861162.

When did LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) receive FDA 510(k) clearance?

LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) received FDA 510(k) clearance on 1986-06-09, under 510(k) number K861162.

Who is the listed applicant for LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)?

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

What is the FDA product code for LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)?

The FDA product code for LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) 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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