SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR— 510(k) K944312

Name: FDA 510(k) clearance K944312
Creator: U.S. Food and Drug Administration
Published: 1994-11-22

Substantially Equivalent

Shelin International Ent., Inc.

FDA 510(k) clearance K944312 for SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR, Substantially Equivalent on 1994-11-22. Applicant: Shelin International Ent., Inc.. Device class: 1.

Clearance details

Applicant: Shelin International Ent., Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-09-02
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.