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FDA 510(k)

MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA

K-Number: K022807 · 2003-01-29

ApplicantCreative Technologies, Inc.
Decision Date2003-01-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA is the device name listed in this FDA 510(k) record. The listed applicant is Creative Technologies, Inc.. It received FDA 510(k) clearance on 2003-01-29 under 510(k) number K022807. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA?

MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA is a medical device that received FDA 510(k) clearance on 2003-01-29. The listed applicant is Creative Technologies, Inc.. The 510(k) number is K022807.

When did MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA receive FDA 510(k) clearance?

MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA received FDA 510(k) clearance on 2003-01-29, under 510(k) number K022807.

Who is the listed applicant for MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA?

The FDA 510(k) record lists Creative Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA?

The FDA product code for MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA is GEX. This falls under the Gastroenterology category.

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Official Source

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