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FDA 510(k)

ELITE CUSTOM

K-Number: K993142 · 1999-12-27

ApplicantSoma Blue, Inc.
Decision Date1999-12-27
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELITE CUSTOM is the device name listed in this FDA 510(k) record. The listed applicant is Soma Blue, Inc.. It received FDA 510(k) clearance on 1999-12-27 under 510(k) number K993142. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITE CUSTOM?

ELITE CUSTOM is a medical device that received FDA 510(k) clearance on 1999-12-27. The listed applicant is Soma Blue, Inc.. The 510(k) number is K993142.

When did ELITE CUSTOM receive FDA 510(k) clearance?

ELITE CUSTOM received FDA 510(k) clearance on 1999-12-27, under 510(k) number K993142.

Who is the listed applicant for ELITE CUSTOM?

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

What is the FDA product code for ELITE CUSTOM?

The FDA product code for ELITE CUSTOM is LKY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Soma Blue, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K993143VITALITY SYSTEM

Related Devices (Code: LKY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.

Official Source

View on FDA Database →

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

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