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FDA 510(k)

ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT

K-Number: K905484 · 1991-02-11

ApplicantMentor Corp.
Decision Date1991-02-11
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K905484. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT?

ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Mentor Corp.. The 510(k) number is K905484.

When did ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT receive FDA 510(k) clearance?

ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905484.

Who is the listed applicant for ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT?

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 ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT?

The FDA product code for ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT 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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