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FDA 510(k)

SILIMED TISSUE EXPANDER

K-Number: K981852 · 1998-08-05

ApplicantSilimed, LLC
Decision Date1998-08-05
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

SILIMED TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Silimed, LLC. It received FDA 510(k) clearance on 1998-08-05 under 510(k) number K981852. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILIMED TISSUE EXPANDER?

SILIMED TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1998-08-05. The listed applicant is Silimed, LLC. The 510(k) number is K981852.

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

SILIMED TISSUE EXPANDER received FDA 510(k) clearance on 1998-08-05, under 510(k) number K981852.

Who is the listed applicant for SILIMED TISSUE EXPANDER?

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

What is the FDA product code for SILIMED TISSUE EXPANDER?

The FDA product code for SILIMED TISSUE EXPANDER is LCJ.

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Other records listing Silimed, LLC 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.

K974479SILIMED VAGINAL STENTK981835SILIMED MALAR IMPLANTK981850SILIMED CHIN IMPLANTSK981851SILIMED SILICONE CARVING BLOCKK981833SILIMED NASAL L SHAPED IMPLANTK980221SILIMED NASAL RETAINER

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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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