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FDA 510(k)

CUI MAMMARY PROTHESIS SIZER

K-Number: K831566 · 1983-08-12

ApplicantCox-Uphuff Intl.
Decision Date1983-08-12
Product CodeMRD
DecisionSubstantially Equivalent

Device Summary

CUI MAMMARY PROTHESIS SIZER is the device name listed in this FDA 510(k) record. The listed applicant is Cox-Uphuff Intl.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K831566. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUI MAMMARY PROTHESIS SIZER?

CUI MAMMARY PROTHESIS SIZER is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Cox-Uphuff Intl.. The 510(k) number is K831566.

When did CUI MAMMARY PROTHESIS SIZER receive FDA 510(k) clearance?

CUI MAMMARY PROTHESIS SIZER received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831566.

Who is the listed applicant for CUI MAMMARY PROTHESIS SIZER?

The FDA 510(k) record lists Cox-Uphuff Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUI MAMMARY PROTHESIS SIZER?

The FDA product code for CUI MAMMARY PROTHESIS SIZER is MRD.

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Other records listing Cox-Uphuff Intl. 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.

K874276CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDERK874342LIGATURE CARRIER/PACKER, HYDROXYLAPATITEK873470TEMPLATEK865056CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDERK871200CUI NASAL SEPTUM BUTTONK865033BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER

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Related Devices (Code: MRD)

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.

K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLCK241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLCK203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllerganK200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLCK131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMentor Worldwide, LLC

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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