SCLERAL SHELL— 510(k) K970320

Name: FDA 510(k) clearance K970320
Creator: U.S. Food and Drug Administration
Published: 1997-07-07

Substantially Equivalent

Xavier A. Guerra, Ocularist, Inc.

FDA 510(k) clearance K970320 for SCLERAL SHELL, Substantially Equivalent on 1997-07-07. Applicant: Xavier A. Guerra, Ocularist, Inc.. Device class: 2.

Clearance details

Applicant: Xavier A. Guerra, Ocularist, Inc.
Product code: Code HQT
Device class: Class 2
Regulation: 21 CFR 886.3800
Advisory panel: Ophthalmic
Date received: 1997-01-28
Decision date: 1997-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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