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FDA 510(k)

OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR

K-Number: K871074 · 1987-04-10

ApplicantOmega Silicone, Inc.
Decision Date1987-04-10
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR is the device name listed in this FDA 510(k) record. The listed applicant is Omega Silicone, Inc.. It received FDA 510(k) clearance on 1987-04-10 under 510(k) number K871074. 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 OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR?

OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR is a medical device that received FDA 510(k) clearance on 1987-04-10. The listed applicant is Omega Silicone, Inc.. The 510(k) number is K871074.

When did OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR receive FDA 510(k) clearance?

OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR received FDA 510(k) clearance on 1987-04-10, under 510(k) number K871074.

Who is the listed applicant for OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR?

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

What is the FDA product code for OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR?

The FDA product code for OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR is FWP.

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Other records listing Omega Silicone, 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.

K871072OMEGA NASAL SEPTAL BUTTONK871070OMEGA SILICONE CHIN IMPLANTK871073OMEGA BIVALVE NASAL SPLINTSK871071OMEGA DORSAL COLUMELLA IMPLANTS

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

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