DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM— 510(k) K003916

Name: FDA 510(k) clearance K003916
Creator: U.S. Food and Drug Administration
Published: 2002-04-15

Substantially Equivalent

Scandia Manufacturing , Ltd.

FDA 510(k) clearance K003916 for DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM, Substantially Equivalent on 2002-04-15. Applicant: Scandia Manufacturing , Ltd.. Device class: 2.

Clearance details

Applicant: Scandia Manufacturing , Ltd.
Product code: Code IMB
Device class: Class 2
Regulation: 21 CFR 890.5250
Advisory panel: Physical Medicine
Date received: 2000-12-19
Decision date: 2002-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

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