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FDA 510(k)

DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM

K-Number: K003916 · 2002-04-15

ApplicantScandia Manufacturing , Ltd.
Decision Date2002-04-15
Product CodeIMB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Scandia Manufacturing , Ltd.. It received FDA 510(k) clearance on 2002-04-15 under 510(k) number K003916. The device is classified under product code IMB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM?

DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-04-15. The listed applicant is Scandia Manufacturing , Ltd.. The 510(k) number is K003916.

When did DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM receive FDA 510(k) clearance?

DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM received FDA 510(k) clearance on 2002-04-15, under 510(k) number K003916.

Who is the listed applicant for DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM?

The FDA 510(k) record lists Scandia Manufacturing , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM?

The FDA product code for DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM is IMB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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