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FDA 510(k)

SCLERAL POWDER

K-Number: K791923 · 1980-01-10

ApplicantOcularists , Ltd.
Decision Date1980-01-10
Product CodeHQH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCLERAL POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Ocularists , Ltd.. It received FDA 510(k) clearance on 1980-01-10 under 510(k) number K791923. 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 SCLERAL POWDER?

SCLERAL POWDER is a medical device that received FDA 510(k) clearance on 1980-01-10. The listed applicant is Ocularists , Ltd.. The 510(k) number is K791923.

When did SCLERAL POWDER receive FDA 510(k) clearance?

SCLERAL POWDER received FDA 510(k) clearance on 1980-01-10, under 510(k) number K791923.

Who is the listed applicant for SCLERAL POWDER?

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

What is the FDA product code for SCLERAL POWDER?

The FDA product code for SCLERAL POWDER is HQH.

Related Clinical Trials

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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.K923167THE NISSEL ARTIFICIAL EYENissel , Ltd.K904962EYE ARTIFICIAL CUSTOMMidwest Eye Laboratories, 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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