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FDA 510(k)

POREX(TM) TISSUE EXPANDER

K-Number: K870154 · 1987-02-24

ApplicantPorex Medical
Decision Date1987-02-24
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

POREX(TM) TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Porex Medical. It received FDA 510(k) clearance on 1987-02-24 under 510(k) number K870154. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POREX(TM) TISSUE EXPANDER?

POREX(TM) TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1987-02-24. The listed applicant is Porex Medical. The 510(k) number is K870154.

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

POREX(TM) TISSUE EXPANDER received FDA 510(k) clearance on 1987-02-24, under 510(k) number K870154.

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

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

What is the FDA product code for POREX(TM) TISSUE EXPANDER?

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

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Other records listing Porex Medical 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.

K872791POREX NERVE LOCATORK873044POREX OTOLOGY INSTRUMENTSK872947POREX QUALITY PLASTIC SURGERY INSTRUMENTSK863946POREX(TM) EXTRA-OCULAR ORBITAL IMPLANTK863943POREX(TM) EYE SPHERE IMPLANTK870257POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.

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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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