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FDA 510(k)

ZARA SOFT TIP CHIN IMPLANT

K-Number: K910458 · 1991-02-19

ApplicantByron Medical
Decision Date1991-02-19
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZARA SOFT TIP CHIN IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K910458. 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 ZARA SOFT TIP CHIN IMPLANT?

ZARA SOFT TIP CHIN IMPLANT is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Byron Medical. The 510(k) number is K910458.

When did ZARA SOFT TIP CHIN IMPLANT receive FDA 510(k) clearance?

ZARA SOFT TIP CHIN IMPLANT received FDA 510(k) clearance on 1991-02-19, under 510(k) number K910458.

Who is the listed applicant for ZARA SOFT TIP CHIN IMPLANT?

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

What is the FDA product code for ZARA SOFT TIP CHIN IMPLANT?

The FDA product code for ZARA SOFT TIP CHIN IMPLANT is FWP.

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Other records listing Byron Medical 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.

K040149PSI-TEC PERISTALTIC INFILTRATION PUMPK001803ACCELERATOR RECIPROCATING CANNULAK981215PSI-TEC LIPOSUCTION ASPIRATORK981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESK980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATIONK980392PSI-TEC ASPIRATOR

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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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