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FDA 510(k)

SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK

K-Number: K982688 · 1998-10-13

ApplicantSpectrum Designs, Inc.
Decision Date1998-10-13
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Designs, Inc.. It received FDA 510(k) clearance on 1998-10-13 under 510(k) number K982688. 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 SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK?

SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK is a medical device that received FDA 510(k) clearance on 1998-10-13. The listed applicant is Spectrum Designs, Inc.. The 510(k) number is K982688.

When did SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK receive FDA 510(k) clearance?

SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK received FDA 510(k) clearance on 1998-10-13, under 510(k) number K982688.

Who is the listed applicant for SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK?

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

What is the FDA product code for SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK?

The FDA product code for SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK is MIB.

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Other records listing Spectrum Designs, 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.

K992522SPECTRUM DESIGNS SPECTRAGELK980462SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANTK980444SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANTK980463SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANTK980445SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANTK980446SPECTRUM DESIGNS ANTERIOR CHIN 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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