NEW ALLEN IMPLANT— 510(k) K900081

Substantially Equivalent

Oculo Plastik, Inc.

FDA 510(k) clearance K900081 for NEW ALLEN IMPLANT, Substantially Equivalent on 1990-03-23. Applicant: Oculo Plastik, Inc.. Device class: 2.

Clearance details

Applicant: Oculo Plastik, Inc.
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 1990-01-04
Decision date: 1990-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, Quebec Canada, CA

Download summary PDF View on FDA.gov ↗

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