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FDA 510(k)

SEARE BIOMEDICAL SILICONE TISSUE EXPANDER

K-Number: K983792 · 1998-12-11

ApplicantSeare Biomedical Corp.
Decision Date1998-12-11
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

SEARE BIOMEDICAL SILICONE TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Seare Biomedical Corp.. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K983792. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEARE BIOMEDICAL SILICONE TISSUE EXPANDER?

SEARE BIOMEDICAL SILICONE TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Seare Biomedical Corp.. The 510(k) number is K983792.

When did SEARE BIOMEDICAL SILICONE TISSUE EXPANDER receive FDA 510(k) clearance?

SEARE BIOMEDICAL SILICONE TISSUE EXPANDER received FDA 510(k) clearance on 1998-12-11, under 510(k) number K983792.

Who is the listed applicant for SEARE BIOMEDICAL SILICONE TISSUE EXPANDER?

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

What is the FDA product code for SEARE BIOMEDICAL SILICONE TISSUE EXPANDER?

The FDA product code for SEARE BIOMEDICAL SILICONE TISSUE EXPANDER is LCJ.

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Other records listing Seare Biomedical 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.

K983630SEARE BIOMEDICAL SILICONE RODSK982752SEARE BIOMEDICAL CHIN IMPLANTSK982753SEARE BIOMEDICAL NASAL IMPLANTSK982763SEARE BIOMEDICAL MALAR IMPLANTSK983043SEARE BIOMEDICAL SILICONE BLOCKK982762SEARE BIOMEDICAL PECTORALIS IMPLANT

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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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