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FDA 510(k)

SILIMED SILICONE CARVING BLOCK

K-Number: K981851 · 1998-07-09

ApplicantSilimed, LLC
Decision Date1998-07-09
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILIMED SILICONE CARVING BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Silimed, LLC. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K981851. 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 SILICONE CARVING BLOCK?

SILIMED SILICONE CARVING BLOCK is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Silimed, LLC. The 510(k) number is K981851.

When did SILIMED SILICONE CARVING BLOCK receive FDA 510(k) clearance?

SILIMED SILICONE CARVING BLOCK received FDA 510(k) clearance on 1998-07-09, under 510(k) number K981851.

Who is the listed applicant for SILIMED SILICONE CARVING BLOCK?

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 SILICONE CARVING BLOCK?

The FDA product code for SILIMED SILICONE CARVING BLOCK 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 IMPLANTSK981833SILIMED NASAL L SHAPED IMPLANTK980221SILIMED NASAL RETAINER

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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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