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FDA 510(k)

DURASIL I AND DURASIL II

K-Number: K973730 · 1997-12-24

ApplicantHanson Medical, Inc.
Decision Date1997-12-24
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DURASIL I AND DURASIL II is the device name listed in this FDA 510(k) record. The listed applicant is Hanson Medical, Inc.. It received FDA 510(k) clearance on 1997-12-24 under 510(k) number K973730. 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 DURASIL I AND DURASIL II?

DURASIL I AND DURASIL II is a medical device that received FDA 510(k) clearance on 1997-12-24. The listed applicant is Hanson Medical, Inc.. The 510(k) number is K973730.

When did DURASIL I AND DURASIL II receive FDA 510(k) clearance?

DURASIL I AND DURASIL II received FDA 510(k) clearance on 1997-12-24, under 510(k) number K973730.

Who is the listed applicant for DURASIL I AND DURASIL II?

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

What is the FDA product code for DURASIL I AND DURASIL II?

The FDA product code for DURASIL I AND DURASIL II is MIB.

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Other records listing Hanson Medical, Inc. as applicant

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K090803HANSON MEDICAL FACIAL IMPLANTSK071018MONARCH NASAL IMPLANTK041690MONARCH NASAL IMPLANTK040307HANSON SCAR ADEK030808HANSON MEDICAL CALF IMPLANTK030809HANSON MEDICAL GLUTEAL 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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