SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS— 510(k) K991995

Name: FDA 510(k) clearance K991995
Creator: U.S. Food and Drug Administration
Published: 1999-08-27

Substantially Equivalent

Softchrome, Inc.

FDA 510(k) clearance K991995 for SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS, Substantially Equivalent on 1999-08-27. Applicant: Softchrome, Inc.. Device class: 2.

Clearance details

Applicant: Softchrome, Inc.
Product code: Code MZD
Device class: Class 2
Regulation: 21 CFR 886.5925
Advisory panel: Ophthalmic
Date received: 1999-06-14
Decision date: 1999-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, US

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