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FDA 510(k)

GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X

K-Number: K052504 · 2005-11-04

ApplicantImplantech Associates, Inc.
Decision Date2005-11-04
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 2005-11-04 under 510(k) number K052504. 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 GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X?

GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X is a medical device that received FDA 510(k) clearance on 2005-11-04. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K052504.

When did GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X receive FDA 510(k) clearance?

GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X received FDA 510(k) clearance on 2005-11-04, under 510(k) number K052504.

Who is the listed applicant for GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X?

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

What is the FDA product code for GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X?

The FDA product code for GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X is MIB.

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Other records listing Implantech Associates, Inc. as applicant

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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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