STORS SCLERAL SPONGE II (LINCOFF DESIGN)— 510(k) K950599

Name: FDA 510(k) clearance K950599
Creator: U.S. Food and Drug Administration
Published: 1995-03-02

Substantially Equivalent

Storz Ophthalmics, Inc.

FDA 510(k) clearance K950599 for STORS SCLERAL SPONGE II (LINCOFF DESIGN), Substantially Equivalent on 1995-03-02. Applicant: Storz Ophthalmics, Inc.. Device class: 2.

Clearance details

Applicant: Storz Ophthalmics, Inc.
Product code: Code HQX
Device class: Class 2
Regulation: 21 CFR 886.3340
Advisory panel: Ophthalmic
Date received: 1995-02-09
Decision date: 1995-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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