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FDA 510(k)

SEARE BIOMEDICAL SILICONE BLOCK

K-Number: K983043 · 1998-09-30

ApplicantSeare Biomedical Corp.
Decision Date1998-09-30
Product CodeMIC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SEARE BIOMEDICAL SILICONE BLOCK 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 1998-09-30 under 510(k) number K983043. The device is classified under product code MIC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEARE BIOMEDICAL SILICONE BLOCK?

SEARE BIOMEDICAL SILICONE BLOCK is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Seare Biomedical Corp.. The 510(k) number is K983043.

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

SEARE BIOMEDICAL SILICONE BLOCK received FDA 510(k) clearance on 1998-09-30, under 510(k) number K983043.

Who is the listed applicant for SEARE BIOMEDICAL SILICONE BLOCK?

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 BLOCK?

The FDA product code for SEARE BIOMEDICAL SILICONE BLOCK is MIC.

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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.

K983792SEARE BIOMEDICAL SILICONE TISSUE EXPANDERK983630SEARE BIOMEDICAL SILICONE RODSK982752SEARE BIOMEDICAL CHIN IMPLANTSK982753SEARE BIOMEDICAL NASAL IMPLANTSK982763SEARE BIOMEDICAL MALAR IMPLANTSK982762SEARE BIOMEDICAL PECTORALIS IMPLANT

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Related Devices (Code: MIC)

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.

K021337AART PECTORALIS IMPLANTAesthetic and Reconstructive Technologies, Inc.K002633SILMAX PECTORAL IMPLANTPillar Surgical, Inc.K982762SEARE BIOMEDICAL PECTORALIS IMPLANTSeare Biomedical Corp.K973729POWERFLEX PEC IMPLANTHanson Medical, Inc.K961072PEC IMPLANTRand Scientific Corp.K944163SPECTRUM DISIGNS PECTORAL IMPLANTSpectrum Designs, 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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