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FDA 510(k)

YOURS TRULY ASYMMETRICAL BREAST FORM

K-Number: K911247 · 1991-03-29

ApplicantJobst Institute, Inc.
Decision Date1991-03-29
Product CodeKCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

YOURS TRULY ASYMMETRICAL BREAST FORM is the device name listed in this FDA 510(k) record. The listed applicant is Jobst Institute, Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K911247. 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 YOURS TRULY ASYMMETRICAL BREAST FORM?

YOURS TRULY ASYMMETRICAL BREAST FORM is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Jobst Institute, Inc.. The 510(k) number is K911247.

When did YOURS TRULY ASYMMETRICAL BREAST FORM receive FDA 510(k) clearance?

YOURS TRULY ASYMMETRICAL BREAST FORM received FDA 510(k) clearance on 1991-03-29, under 510(k) number K911247.

Who is the listed applicant for YOURS TRULY ASYMMETRICAL BREAST FORM?

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

What is the FDA product code for YOURS TRULY ASYMMETRICAL BREAST FORM?

The FDA product code for YOURS TRULY ASYMMETRICAL BREAST FORM is KCZ.

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Other records listing Jobst Institute, 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.

K955138ANTI-EM/GP STOCKINGSK953763GLADIATOR ANTISHOCK PANTSK925583JOBSKIN CONTINUING CAREK925154JOBST-CUSTOMK934639JOBST ATHROMBIC PUMP - SYSTEM 2500K922681CUTINOVA FOAM

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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 GmbHK932899CLASSIQUEHemispheres Marketing Co. , Ltd.K933668ALMOST U, INC. BREAST PROSTHESISAlmost U., Inc.

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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