MICROVISION SCLERAL BUCKLING COMPONENTS— 510(k) K023481

Name: FDA 510(k) clearance K023481
Creator: U.S. Food and Drug Administration
Published: 2003-01-08

Substantially Equivalent

Microvision, Inc.

FDA 510(k) clearance K023481 for MICROVISION SCLERAL BUCKLING COMPONENTS, Substantially Equivalent on 2003-01-08. Applicant: Microvision, Inc.. Device class: 2.

Clearance details

Applicant: Microvision, Inc.
Product code: Code HQX
Device class: Class 2
Regulation: 21 CFR 886.3340
Advisory panel: Ophthalmic
Date received: 2002-10-17
Decision date: 2003-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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K963219 — RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES1996-10-28
K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS1996-06-05
K950599 — STORS SCLERAL SPONGE II (LINCOFF DESIGN)1995-03-02

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K022186 — SCLERAL PLUGS, 19 AND 20 GAUGE2003-02-26
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