ZIMLITE LENS— 510(k) K861960

Name: FDA 510(k) clearance K861960
Creator: U.S. Food and Drug Administration
Published: 1986-06-09

Substantially Equivalent

Asahi Optical Co. C/O Rosati Associates, P.C.

FDA 510(k) clearance K861960 for ZIMLITE LENS, Substantially Equivalent on 1986-06-09. Applicant: Asahi Optical Co. C/O Rosati Associates, P.C.. Device class: 1.

Clearance details

Applicant: Asahi Optical Co. C/O Rosati Associates, P.C.
Product code: Code HQG
Device class: Class 1
Regulation: 21 CFR 886.5844
Advisory panel: Ophthalmic
Date received: 1986-05-20
Decision date: 1986-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Japan, JP

Download summary PDF View on FDA.gov ↗

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