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FDA 510(k)

CERAVITAL CERAMIC EAR CANAL WALL PROSTH

K-Number: K813224 · 1982-04-21

ApplicantXomed, Inc.
Decision Date1982-04-21
Product CodeESF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERAVITAL CERAMIC EAR CANAL WALL PROSTH is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1982-04-21 under 510(k) number K813224. The device is classified under product code ESF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAVITAL CERAMIC EAR CANAL WALL PROSTH?

CERAVITAL CERAMIC EAR CANAL WALL PROSTH is a medical device that received FDA 510(k) clearance on 1982-04-21. The listed applicant is Xomed, Inc.. The 510(k) number is K813224.

When did CERAVITAL CERAMIC EAR CANAL WALL PROSTH receive FDA 510(k) clearance?

CERAVITAL CERAMIC EAR CANAL WALL PROSTH received FDA 510(k) clearance on 1982-04-21, under 510(k) number K813224.

Who is the listed applicant for CERAVITAL CERAMIC EAR CANAL WALL PROSTH?

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 CERAVITAL CERAMIC EAR CANAL WALL PROSTH?

The FDA product code for CERAVITAL CERAMIC EAR CANAL WALL PROSTH is ESF.

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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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Related Devices (Code: ESF)

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.

K891247BEHIND-THE-EAR HEARING AID MODEL 404 PP-PCSiemens Hearing Instruments, 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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