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FDA 510(k)

SILICONE BLOCK

K-Number: K042380 · 2004-10-25

ApplicantNational Medical Devices, Inc.
Decision Date2004-10-25
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILICONE BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Devices, Inc.. It received FDA 510(k) clearance on 2004-10-25 under 510(k) number K042380. 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 SILICONE BLOCK?

SILICONE BLOCK is a medical device that received FDA 510(k) clearance on 2004-10-25. The listed applicant is National Medical Devices, Inc.. The 510(k) number is K042380.

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

SILICONE BLOCK received FDA 510(k) clearance on 2004-10-25, under 510(k) number K042380.

Who is the listed applicant for SILICONE BLOCK?

The FDA 510(k) record lists National Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILICONE BLOCK?

The FDA product code for SILICONE BLOCK is MIB.

Related Clinical Trials

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.

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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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