GORE SPHEREX IMPLANT— 510(k) K962241

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K962241 for GORE SPHEREX IMPLANT, Substantially Equivalent on 1996-08-22. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code HPZ
Advisory panel: Ophthalmic
Date received: 1996-06-11
Decision date: 1996-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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