EASY CONTROL MICRO INSERTER, MODEL ON385— 510(k) K011498

Name: FDA 510(k) clearance K011498
Creator: U.S. Food and Drug Administration
Published: 2001-07-09

Substantially Equivalent

Ophtec USA, Inc.

FDA 510(k) clearance K011498 for EASY CONTROL MICRO INSERTER, MODEL ON385, Substantially Equivalent on 2001-07-09. Applicant: Ophtec USA, Inc.. Device class: 1.

Clearance details

Applicant: Ophtec USA, Inc.
Product code: Code NCE
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 2001-05-15
Decision date: 2001-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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