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FDA 510(k)

MEDISIL SILICONE SHEETING

K-Number: K040042 · 2004-04-01

ApplicantMedisil Corporation
Decision Date2004-04-01
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEDISIL SILICONE SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Medisil Corporation. It received FDA 510(k) clearance on 2004-04-01 under 510(k) number K040042. 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 MEDISIL SILICONE SHEETING?

MEDISIL SILICONE SHEETING is a medical device that received FDA 510(k) clearance on 2004-04-01. The listed applicant is Medisil Corporation. The 510(k) number is K040042.

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

MEDISIL SILICONE SHEETING received FDA 510(k) clearance on 2004-04-01, under 510(k) number K040042.

Who is the listed applicant for MEDISIL SILICONE SHEETING?

The FDA 510(k) record lists Medisil Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDISIL SILICONE SHEETING?

The FDA product code for MEDISIL SILICONE SHEETING is MIB.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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