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FDA 510(k)

CHIN WAFER

K-Number: K921581 · 1992-05-06

ApplicantImplantech Associates, Inc.
Decision Date1992-05-06
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHIN WAFER 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 1992-05-06 under 510(k) number K921581. 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 CHIN WAFER?

CHIN WAFER is a medical device that received FDA 510(k) clearance on 1992-05-06. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K921581.

When did CHIN WAFER receive FDA 510(k) clearance?

CHIN WAFER received FDA 510(k) clearance on 1992-05-06, under 510(k) number K921581.

Who is the listed applicant for CHIN WAFER?

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 CHIN WAFER?

The FDA product code for CHIN WAFER 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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