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FDA 510(k)

MCGHAN INTEGRAL VALVE TISSUE EXPANDER

K-Number: K854794 · 1985-12-24

ApplicantMcghan Medical Corp.
Decision Date1985-12-24
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

MCGHAN INTEGRAL VALVE TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Mcghan Medical Corp.. It received FDA 510(k) clearance on 1985-12-24 under 510(k) number K854794. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCGHAN INTEGRAL VALVE TISSUE EXPANDER?

MCGHAN INTEGRAL VALVE TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1985-12-24. The listed applicant is Mcghan Medical Corp.. The 510(k) number is K854794.

When did MCGHAN INTEGRAL VALVE TISSUE EXPANDER receive FDA 510(k) clearance?

MCGHAN INTEGRAL VALVE TISSUE EXPANDER received FDA 510(k) clearance on 1985-12-24, under 510(k) number K854794.

Who is the listed applicant for MCGHAN INTEGRAL VALVE TISSUE EXPANDER?

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

What is the FDA product code for MCGHAN INTEGRAL VALVE TISSUE EXPANDER?

The FDA product code for MCGHAN INTEGRAL VALVE TISSUE EXPANDER is LCJ.

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Other records listing Mcghan Medical 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.

K873475MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURSK873476MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURSK870754MCGHAN TISSUE EXPANDER FILL SYSTEMK864184MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGNK864185MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGNK862203MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER

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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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