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FDA 510(k)

OMEGA NASAL SEPTAL BUTTON

K-Number: K871072 · 1987-06-08

ApplicantOmega Silicone, Inc.
Decision Date1987-06-08
Product CodeLFB
DecisionSubstantially Equivalent

Device Summary

OMEGA NASAL SEPTAL BUTTON 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 1987-06-08 under 510(k) number K871072. The device is classified under product code LFB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA NASAL SEPTAL BUTTON?

OMEGA NASAL SEPTAL BUTTON is a medical device that received FDA 510(k) clearance on 1987-06-08. The listed applicant is Omega Silicone, Inc.. The 510(k) number is K871072.

When did OMEGA NASAL SEPTAL BUTTON receive FDA 510(k) clearance?

OMEGA NASAL SEPTAL BUTTON received FDA 510(k) clearance on 1987-06-08, under 510(k) number K871072.

Who is the listed applicant for OMEGA NASAL SEPTAL BUTTON?

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 NASAL SEPTAL BUTTON?

The FDA product code for OMEGA NASAL SEPTAL BUTTON is LFB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K871070OMEGA SILICONE CHIN IMPLANTK871073OMEGA BIVALVE NASAL SPLINTSK871071OMEGA DORSAL COLUMELLA IMPLANTSK871074OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR

Related Devices (Code: LFB)

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.

K131745BLOM-SINGER SEPTAL PERFORATION PROSTHESISHelix Medical, LLCK013696SILMED NASAL SEPTAL BUTTONSilmed, Inc.K982667MICROMEDICS NASAL SEPTAL BUTTONMicromedics, Inc.K972060NASAL SEPTAL BUTTONBoston Medical Products, Inc.K920994HOOD NASAL SEPTAL BUTTONHood LaboratoriesK901366INVOTEC SEPTAL BUTTONInvotec International, Inc.

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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