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FDA 510(k)

OSTEO-MESH CRANIAL FAIRING

K-Number: K860491 · 1986-03-28

ApplicantXomed, Inc.
Decision Date1986-03-28
Product Code
DecisionSubstantially Equivalent

Device Summary

OSTEO-MESH CRANIAL FAIRING is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1986-03-28 under 510(k) number K860491. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEO-MESH CRANIAL FAIRING?

OSTEO-MESH CRANIAL FAIRING is a medical device that received FDA 510(k) clearance on 1986-03-28. The listed applicant is Xomed, Inc.. The 510(k) number is K860491.

When did OSTEO-MESH CRANIAL FAIRING receive FDA 510(k) clearance?

OSTEO-MESH CRANIAL FAIRING received FDA 510(k) clearance on 1986-03-28, under 510(k) number K860491.

Who is the listed applicant for OSTEO-MESH CRANIAL FAIRING?

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

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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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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