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FDA 510(k)

CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER

K-Number: K865056 · 1987-05-22

ApplicantCox-Uphuff Intl.
Decision Date1987-05-22
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER 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 1987-05-22 under 510(k) number K865056. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER?

CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1987-05-22. The listed applicant is Cox-Uphuff Intl.. The 510(k) number is K865056.

When did CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER receive FDA 510(k) clearance?

CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER received FDA 510(k) clearance on 1987-05-22, under 510(k) number K865056.

Who is the listed applicant for CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER?

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 TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER?

The FDA product code for CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER is LCJ.

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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, HYDROXYLAPATITEK873470TEMPLATEK871200CUI NASAL SEPTUM BUTTONK865033BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDERK854339CUI CHIN SIZER

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Related Devices (Code: LCJ)

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.

K254126Natrelle 133S Tissue ExpandersAbbVieK242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLCK243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLCK214124AlloX2 Pro Tissue ExpandersSientra, 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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