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FDA 510(k)

IMPLANTECH MEDICAL GRADE SILICONE SHEETING

K-Number: K944408 · 1994-11-09

ApplicantKing & Spalding
Decision Date1994-11-09
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IMPLANTECH MEDICAL GRADE SILICONE SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is King & Spalding. It received FDA 510(k) clearance on 1994-11-09 under 510(k) number K944408. 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 IMPLANTECH MEDICAL GRADE SILICONE SHEETING?

IMPLANTECH MEDICAL GRADE SILICONE SHEETING is a medical device that received FDA 510(k) clearance on 1994-11-09. The listed applicant is King & Spalding. The 510(k) number is K944408.

When did IMPLANTECH MEDICAL GRADE SILICONE SHEETING receive FDA 510(k) clearance?

IMPLANTECH MEDICAL GRADE SILICONE SHEETING received FDA 510(k) clearance on 1994-11-09, under 510(k) number K944408.

Who is the listed applicant for IMPLANTECH MEDICAL GRADE SILICONE SHEETING?

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

What is the FDA product code for IMPLANTECH MEDICAL GRADE SILICONE SHEETING?

The FDA product code for IMPLANTECH MEDICAL GRADE SILICONE SHEETING is MIB.

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Other records listing King & Spalding 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.

K942423NAIS WRIST BLOOD PRESSURE METERK942422PANASONIC WRIST BLOOD PRESSURE METERK945998CHIN IMPLANT STYLE IK942420IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANTK942421IMPLANTECH LATERAL MANDIBULAR BAR IMPLANTK941972HEMO-O-LOK

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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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