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FDA 510(k)

LIFECELL TISSUE EXPANDER

K-Number: K112534 · 2012-08-10

ApplicantLifecell Corp.
Decision Date2012-08-10
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

LIFECELL TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corp.. It received FDA 510(k) clearance on 2012-08-10 under 510(k) number K112534. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFECELL TISSUE EXPANDER?

LIFECELL TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 2012-08-10. The listed applicant is Lifecell Corp.. The 510(k) number is K112534.

When did LIFECELL TISSUE EXPANDER receive FDA 510(k) clearance?

LIFECELL TISSUE EXPANDER received FDA 510(k) clearance on 2012-08-10, under 510(k) number K112534.

Who is the listed applicant for LIFECELL TISSUE EXPANDER?

The FDA 510(k) record lists Lifecell Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFECELL TISSUE EXPANDER?

The FDA product code for LIFECELL TISSUE EXPANDER is LCJ.

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Other records listing Lifecell Corp. 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.

K130817LTN - LAPAROSCOPIC SURGICAL MESHK121289LTM-LABAROSCOPIC SURGICAL MESHK082176LTM-BPS SURGICAL MESHK082103LTM WOUND DRESSINGK080353LTM-T SURGICAL MESHK071986LTM-RC SURGICAL MESH

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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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