OCULAR CONFORMER— 510(k) K970318

Name: FDA 510(k) clearance K970318
Creator: U.S. Food and Drug Administration
Published: 1997-07-07

Substantially Equivalent

Southwest Artificial Eyes, Inc.

FDA 510(k) clearance K970318 for OCULAR CONFORMER, Substantially Equivalent on 1997-07-07. Applicant: Southwest Artificial Eyes, Inc.. Device class: 2.

Clearance details

Applicant: Southwest Artificial Eyes, Inc.
Product code: Code HQN
Device class: Class 2
Regulation: 21 CFR 886.3130
Advisory panel: Ophthalmic
Date received: 1997-01-28
Decision date: 1997-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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