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FDA 510(k)

3-D ACCUSCAN FACIAL IMPLANTS

K-Number: K913761 · 1991-10-17

ApplicantImplantech Associates, Inc.
Decision Date1991-10-17
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3-D ACCUSCAN FACIAL IMPLANTS 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 1991-10-17 under 510(k) number K913761. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3-D ACCUSCAN FACIAL IMPLANTS?

3-D ACCUSCAN FACIAL IMPLANTS is a medical device that received FDA 510(k) clearance on 1991-10-17. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K913761.

When did 3-D ACCUSCAN FACIAL IMPLANTS receive FDA 510(k) clearance?

3-D ACCUSCAN FACIAL IMPLANTS received FDA 510(k) clearance on 1991-10-17, under 510(k) number K913761.

Who is the listed applicant for 3-D ACCUSCAN FACIAL IMPLANTS?

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 3-D ACCUSCAN FACIAL IMPLANTS?

The FDA product code for 3-D ACCUSCAN FACIAL IMPLANTS is FWP.

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Other records listing Implantech Associates, 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.

K200610Customized Contour ImplantK191130Customized Contour ImplantK172389ePTFE-Coated Auricular ImplantK071470IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXXK052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-XK052505CALF IMPLANT, MODEL EC17-X

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Related Devices (Code: FWP)

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.

K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KGK232593FITme Customized Silicone ImplantKeosan Trading Co.K200610Customized Contour ImplantImplantech Associates, Inc.K191130Customized Contour ImplantImplantech Associates, Inc.K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KGK153508Stryker CMF MEDPOR Customized ImplantStryker

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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