SCLERAL SHELL— 510(k) K970327

Substantially Equivalent

Southwest Artificial Eyes, Inc.

FDA 510(k) clearance K970327 for SCLERAL SHELL, Substantially Equivalent on 1997-07-07. Applicant: Southwest Artificial Eyes, Inc..

Clearance details

Applicant: Southwest Artificial Eyes, Inc.
Product code: Code HQT
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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