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FDA 510(k)

MENTOR HORIZON LOW VISION MAGNIFIER

K-Number: K915340 · 1992-03-30

ApplicantMentor O & O, Inc.
Decision Date1992-03-30
Product CodeHJG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENTOR HORIZON LOW VISION MAGNIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Mentor O & O, Inc.. It received FDA 510(k) clearance on 1992-03-30 under 510(k) number K915340. The device is classified under product code HJG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR HORIZON LOW VISION MAGNIFIER?

MENTOR HORIZON LOW VISION MAGNIFIER is a medical device that received FDA 510(k) clearance on 1992-03-30. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K915340.

When did MENTOR HORIZON LOW VISION MAGNIFIER receive FDA 510(k) clearance?

MENTOR HORIZON LOW VISION MAGNIFIER received FDA 510(k) clearance on 1992-03-30, under 510(k) number K915340.

Who is the listed applicant for MENTOR HORIZON LOW VISION MAGNIFIER?

The FDA 510(k) record lists Mentor O & O, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENTOR HORIZON LOW VISION MAGNIFIER?

The FDA product code for MENTOR HORIZON LOW VISION MAGNIFIER is HJG.

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Other records listing Mentor O & O, 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.

K955245MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEMK934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONK912904MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEMK910637MENTOR(R) SUR-E-TROL(R)K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305K903878MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT

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Related Devices (Code: HJG)

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.

K933633LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATEGracefully Yours, Inc.K920069MAGNI-CAMInnoventions, Inc.K892351MAGNILINK SYSTEM 602Coburn Optical Ind., Inc.K892350MAGNILINK SYSTEM 402/5Coburn Optical Ind., Inc.K892347MAGNILINK SYSTEM 101Coburn Optical Ind., Inc.K892348MAGNILINK SYSTEM 201Coburn Optical Ind., Inc.

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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