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FDA 510(k)

SILICONE CARVING BLOCK

K-Number: K973728 · 1997-11-13

ApplicantHanson Medical, Inc.
Decision Date1997-11-13
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILICONE CARVING BLOCK 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 1997-11-13 under 510(k) number K973728. 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 CARVING BLOCK?

SILICONE CARVING BLOCK is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Hanson Medical, Inc.. The 510(k) number is K973728.

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

SILICONE CARVING BLOCK received FDA 510(k) clearance on 1997-11-13, under 510(k) number K973728.

Who is the listed applicant for SILICONE CARVING BLOCK?

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 SILICONE CARVING BLOCK?

The FDA product code for SILICONE CARVING BLOCK is MIB.

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Other records listing Hanson Medical, Inc. 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.

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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