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FDA 510(k)

SEARE BIOMEDICAL SILICONE SHEETING

K-Number: K983041 · 1998-09-30

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

Device Summary

SEARE BIOMEDICAL SILICONE SHEETING 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 K983041. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEARE BIOMEDICAL SILICONE SHEETING?

SEARE BIOMEDICAL SILICONE SHEETING 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 K983041.

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

SEARE BIOMEDICAL SILICONE SHEETING received FDA 510(k) clearance on 1998-09-30, under 510(k) number K983041.

Who is the listed applicant for SEARE BIOMEDICAL SILICONE SHEETING?

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 SHEETING?

The FDA product code for SEARE BIOMEDICAL SILICONE SHEETING is MIB.

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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: MIB)

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.

K241150MISTI Silicone ImplantKeosan Trading Co.K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.K200073AugMENTA Penile ImplantAugmenta, LLCK220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.K193392BioSiCar Silicone ImplantMetalware Technology Corp.

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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