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FDA 510(k)

THE NISSEL ARTIFICIAL EYE

K-Number: K923167 · 1992-09-02

ApplicantNissel , Ltd.
Decision Date1992-09-02
Product CodeHQH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

THE NISSEL ARTIFICIAL EYE is the device name listed in this FDA 510(k) record. The listed applicant is Nissel , Ltd.. It received FDA 510(k) clearance on 1992-09-02 under 510(k) number K923167. The device is classified under product code HQH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE NISSEL ARTIFICIAL EYE?

THE NISSEL ARTIFICIAL EYE is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Nissel , Ltd.. The 510(k) number is K923167.

When did THE NISSEL ARTIFICIAL EYE receive FDA 510(k) clearance?

THE NISSEL ARTIFICIAL EYE received FDA 510(k) clearance on 1992-09-02, under 510(k) number K923167.

Who is the listed applicant for THE NISSEL ARTIFICIAL EYE?

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

What is the FDA product code for THE NISSEL ARTIFICIAL EYE?

The FDA product code for THE NISSEL ARTIFICIAL EYE is HQH.

Related Clinical Trials

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.

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Other records listing Nissel , Ltd. 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.

K990281S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

Related Devices (Code: HQH)

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.

K952538ROBERT B. SCOTT PLASTIC ARTIFICALRobert B. Scott Ocularists of Florida, Inc.K945270CUSTOM ARTIFICIAL HUMAN EYESDaniel T AcostaK946226CUSTOM OCULAR PROSTHESISFrank Tanaka, Ocularist, Inc.K904962EYE ARTIFICIAL CUSTOMMidwest Eye Laboratories, Inc.K791923SCLERAL POWDEROcularists , Ltd.

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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