OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS— 510(k) K911110

Name: FDA 510(k) clearance K911110
Creator: U.S. Food and Drug Administration
Published: 1991-06-18

Substantially Equivalent

G.W.B. Intl., Ltd.

FDA 510(k) clearance K911110 for OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS, Substantially Equivalent on 1991-06-18. Applicant: G.W.B. Intl., Ltd.. Device class: 2.

Clearance details

Applicant: G.W.B. Intl., Ltd.
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 1991-03-04
Decision date: 1991-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sudbury, MA, US

Download summary PDF View on FDA.gov ↗

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