SUPER VIEW DISPOSABLE BIOM LENS SET— 510(k) K051630

Name: FDA 510(k) clearance K051630
Creator: U.S. Food and Drug Administration
Published: 2005-06-29

Substantially Equivalent

Insight Instruments, Inc.

FDA 510(k) clearance K051630 for SUPER VIEW DISPOSABLE BIOM LENS SET, Substantially Equivalent on 2005-06-29. Applicant: Insight Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Insight Instruments, Inc.
Product code: Code HJK
Device class: Class 2
Regulation: 21 CFR 886.1385
Advisory panel: Ophthalmic
Date received: 2005-06-17
Decision date: 2005-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sanford, FL, US

Download summary PDF View on FDA.gov ↗

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