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FDA 510(k)

ROBINSON MIDDLE EAR PROSTHESIS

K-Number: K760570 · 1976-09-21

ApplicantXomed, Inc.
Decision Date1976-09-21
Product CodeEIB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROBINSON MIDDLE EAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1976-09-21 under 510(k) number K760570. The device is classified under product code EIB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROBINSON MIDDLE EAR PROSTHESIS?

ROBINSON MIDDLE EAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 1976-09-21. The listed applicant is Xomed, Inc.. The 510(k) number is K760570.

When did ROBINSON MIDDLE EAR PROSTHESIS receive FDA 510(k) clearance?

ROBINSON MIDDLE EAR PROSTHESIS received FDA 510(k) clearance on 1976-09-21, under 510(k) number K760570.

Who is the listed applicant for ROBINSON MIDDLE EAR PROSTHESIS?

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 ROBINSON MIDDLE EAR PROSTHESIS?

The FDA product code for ROBINSON MIDDLE EAR PROSTHESIS is EIB.

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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: EIB)

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.

K911118DTF-1000LL,DTF-1000Cp MedicalK874543MODEL OPO-32 IRRIGATION SLEEVEAllergan, Inc.K822411SYSTEM 80 FACEPLATE-IN-THE-EAR #F1Western Advanced Technology, 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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