SCLERAL POWDER— 510(k) K791923

Substantially Equivalent

Ocularists , Ltd.

FDA 510(k) clearance K791923 for SCLERAL POWDER, Substantially Equivalent on 1980-01-10. Applicant: Ocularists , Ltd.. Device class: 1.

Clearance details

Applicant: Ocularists , Ltd.
Product code: Code HQH
Device class: Class 1
Regulation: 21 CFR 886.3200
Advisory panel: Ophthalmic
Date received: 1979-09-26
Decision date: 1980-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code HQH

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K946226 — CUSTOM OCULAR PROSTHESIS1995-03-22
K923167 — THE NISSEL ARTIFICIAL EYE1992-09-02
K904962 — EYE ARTIFICIAL CUSTOM1991-08-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.