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FDA 510(k)

CLASSIQUE

K-Number: K932899 · 1993-12-16

ApplicantHemispheres Marketing Co. , Ltd.
Decision Date1993-12-16
Product CodeKCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLASSIQUE is the device name listed in this FDA 510(k) record. The listed applicant is Hemispheres Marketing Co. , Ltd.. It received FDA 510(k) clearance on 1993-12-16 under 510(k) number K932899. The device is classified under product code KCZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLASSIQUE?

CLASSIQUE is a medical device that received FDA 510(k) clearance on 1993-12-16. The listed applicant is Hemispheres Marketing Co. , Ltd.. The 510(k) number is K932899.

When did CLASSIQUE receive FDA 510(k) clearance?

CLASSIQUE received FDA 510(k) clearance on 1993-12-16, under 510(k) number K932899.

Who is the listed applicant for CLASSIQUE?

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

What is the FDA product code for CLASSIQUE?

The FDA product code for CLASSIQUE is KCZ.

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Related Devices (Code: KCZ)

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.

K990458STRAUMANN EXTRAORAL IMPLANT SYSTEMStraumann USAK951324MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESISMaxol Limited L.C.K933465COSMETGreat Bay Medical Products, Inc.K932978CALSSIQUE OR MYSTIQUEDekumed, Kunststofftechnik Degler GmbHK933668ALMOST U, INC. BREAST PROSTHESISAlmost U., Inc.K921535SUOENA AFFINITY (TM) MODEL #802Coloplast Corp.

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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