FI, GORDY TOY, WELLJOY AND OTHERS— 510(k) K946004

Name: FDA 510(k) clearance K946004
Creator: U.S. Food and Drug Administration
Published: 1995-01-31

Substantially Equivalent

Fundamental Industrial Co., Ltd.

FDA 510(k) clearance K946004 for FI, GORDY TOY, WELLJOY AND OTHERS, Substantially Equivalent on 1995-01-31. Applicant: Fundamental Industrial Co., Ltd.. Device class: 1.

Clearance details

Applicant: Fundamental Industrial Co., Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-12-09
Decision date: 1995-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kowloon, Hong Kong, HK

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