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FDA 510(k)

SEARE BIOMEDICAL PECTORALIS IMPLANT

K-Number: K982762 · 1998-09-30

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

Device Summary

SEARE BIOMEDICAL PECTORALIS IMPLANT 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 K982762. 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 PECTORALIS IMPLANT?

SEARE BIOMEDICAL PECTORALIS IMPLANT 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 K982762.

When did SEARE BIOMEDICAL PECTORALIS IMPLANT receive FDA 510(k) clearance?

SEARE BIOMEDICAL PECTORALIS IMPLANT received FDA 510(k) clearance on 1998-09-30, under 510(k) number K982762.

Who is the listed applicant for SEARE BIOMEDICAL PECTORALIS IMPLANT?

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 PECTORALIS IMPLANT?

The FDA product code for SEARE BIOMEDICAL PECTORALIS IMPLANT 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 IMPLANTSK983043SEARE BIOMEDICAL SILICONE BLOCK

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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.K983043SEARE BIOMEDICAL SILICONE BLOCKSeare 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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