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FDA 510(k)

MENTOR EXPANDER MAMMARY PROSTHESIS

K-Number: K844813 · 1985-05-10

ApplicantMentor Corp.
Decision Date1985-05-10
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

MENTOR EXPANDER MAMMARY PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1985-05-10 under 510(k) number K844813. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR EXPANDER MAMMARY PROSTHESIS?

MENTOR EXPANDER MAMMARY PROSTHESIS is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Mentor Corp.. The 510(k) number is K844813.

When did MENTOR EXPANDER MAMMARY PROSTHESIS receive FDA 510(k) clearance?

MENTOR EXPANDER MAMMARY PROSTHESIS received FDA 510(k) clearance on 1985-05-10, under 510(k) number K844813.

Who is the listed applicant for MENTOR EXPANDER MAMMARY PROSTHESIS?

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

What is the FDA product code for MENTOR EXPANDER MAMMARY PROSTHESIS?

The FDA product code for MENTOR EXPANDER MAMMARY PROSTHESIS is LCJ.

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Other records listing Mentor 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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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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