SILHOUETTE, SUNLIMETED,ADIDAS— 510(k) K944160

Name: FDA 510(k) clearance K944160
Creator: U.S. Food and Drug Administration
Published: 1994-09-28

Substantially Equivalent

Silhouette Optical , Ltd.

FDA 510(k) clearance K944160 for SILHOUETTE, SUNLIMETED,ADIDAS, Substantially Equivalent on 1994-09-28. Applicant: Silhouette Optical , Ltd.. Device class: 1.

Clearance details

Applicant: Silhouette Optical , Ltd.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1994-08-26
Decision date: 1994-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northvale, NJ, US

Download summary PDF View on FDA.gov ↗

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