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FDA 510(k)

SEPTAL BUTTON

K-Number: K781529 · 1978-10-17

ApplicantXomed, Inc.
Decision Date1978-10-17
Product CodeLFB
DecisionSubstantially Equivalent

Device Summary

SEPTAL BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1978-10-17 under 510(k) number K781529. The device is classified under product code LFB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEPTAL BUTTON?

SEPTAL BUTTON is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is Xomed, Inc.. The 510(k) number is K781529.

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

SEPTAL BUTTON received FDA 510(k) clearance on 1978-10-17, under 510(k) number K781529.

Who is the listed applicant for SEPTAL BUTTON?

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

What is the FDA product code for SEPTAL BUTTON?

The FDA product code for 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.

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Other records listing Xomed, 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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

View all 82 devices →

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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