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FDA 510(k)

MAGNILINK SYSTEM 201

K-Number: K892348 · 1989-05-26

ApplicantCoburn Optical Ind., Inc.
Decision Date1989-05-26
Product CodeHJG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAGNILINK SYSTEM 201 is the device name listed in this FDA 510(k) record. The listed applicant is Coburn Optical Ind., Inc.. It received FDA 510(k) clearance on 1989-05-26 under 510(k) number K892348. 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 MAGNILINK SYSTEM 201?

MAGNILINK SYSTEM 201 is a medical device that received FDA 510(k) clearance on 1989-05-26. The listed applicant is Coburn Optical Ind., Inc.. The 510(k) number is K892348.

When did MAGNILINK SYSTEM 201 receive FDA 510(k) clearance?

MAGNILINK SYSTEM 201 received FDA 510(k) clearance on 1989-05-26, under 510(k) number K892348.

Who is the listed applicant for MAGNILINK SYSTEM 201?

The FDA 510(k) record lists Coburn Optical Ind., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNILINK SYSTEM 201?

The FDA product code for MAGNILINK SYSTEM 201 is HJG.

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Other records listing Coburn Optical Ind., 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.

K892347MAGNILINK SYSTEM 101K892350MAGNILINK SYSTEM 402/5K892349MAGNILINK SYSTEM 209K892351MAGNILINK SYSTEM 602K862188IRRIGATION & ASPIRATION/VITRECTOMY DEVICEK853457COBURN I/A SYSTEM

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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.K915340MENTOR HORIZON LOW VISION MAGNIFIERMentor O & O, Inc.K920069MAGNI-CAMInnoventions, Inc.K892350MAGNILINK SYSTEM 402/5Coburn Optical Ind., Inc.K892347MAGNILINK SYSTEM 101Coburn Optical Ind., Inc.K892349MAGNILINK SYSTEM 209Coburn 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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