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FDA 510(k)

SILIMED GLUTEAL IMPLANT

K-Number: K974482 · 1998-02-24

ApplicantSilimed, LLC
Decision Date1998-02-24
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILIMED GLUTEAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Silimed, LLC. It received FDA 510(k) clearance on 1998-02-24 under 510(k) number K974482. 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 SILIMED GLUTEAL IMPLANT?

SILIMED GLUTEAL IMPLANT is a medical device that received FDA 510(k) clearance on 1998-02-24. The listed applicant is Silimed, LLC. The 510(k) number is K974482.

When did SILIMED GLUTEAL IMPLANT receive FDA 510(k) clearance?

SILIMED GLUTEAL IMPLANT received FDA 510(k) clearance on 1998-02-24, under 510(k) number K974482.

Who is the listed applicant for SILIMED GLUTEAL IMPLANT?

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 GLUTEAL IMPLANT?

The FDA product code for SILIMED GLUTEAL IMPLANT is MIB.

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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.

K981852SILIMED TISSUE EXPANDERK974479SILIMED VAGINAL STENTK981835SILIMED MALAR IMPLANTK981850SILIMED CHIN IMPLANTSK981851SILIMED SILICONE CARVING BLOCKK981833SILIMED NASAL L SHAPED IMPLANT

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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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