FORMALENS 2000— 510(k) K863367

Name: FDA 510(k) clearance K863367
Creator: U.S. Food and Drug Administration
Published: 1986-09-26

Substantially Equivalent for Some Indications

Vision-Sciences, Inc.

FDA 510(k) clearance K863367 for FORMALENS 2000, Substantially Equivalent for Some Indications on 1986-09-26. Applicant: Vision-Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Vision-Sciences, Inc.
Product code: Code HQG
Device class: Class 1
Regulation: 21 CFR 886.5844
Advisory panel: Ophthalmic
Date received: 1986-09-03
Decision date: 1986-09-26
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

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