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FDA 510(k)

IONOS(R) OSSICLE 5MM & 7MM

K-Number: K911583 · 1991-09-09

ApplicantIonos GmbH & Co. KG
Decision Date1991-09-09
Product CodeETA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IONOS(R) OSSICLE 5MM & 7MM is the device name listed in this FDA 510(k) record. The listed applicant is Ionos GmbH & Co. KG. It received FDA 510(k) clearance on 1991-09-09 under 510(k) number K911583. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IONOS(R) OSSICLE 5MM & 7MM?

IONOS(R) OSSICLE 5MM & 7MM is a medical device that received FDA 510(k) clearance on 1991-09-09. The listed applicant is Ionos GmbH & Co. KG. The 510(k) number is K911583.

When did IONOS(R) OSSICLE 5MM & 7MM receive FDA 510(k) clearance?

IONOS(R) OSSICLE 5MM & 7MM received FDA 510(k) clearance on 1991-09-09, under 510(k) number K911583.

Who is the listed applicant for IONOS(R) OSSICLE 5MM & 7MM?

The FDA 510(k) record lists Ionos GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IONOS(R) OSSICLE 5MM & 7MM?

The FDA product code for IONOS(R) OSSICLE 5MM & 7MM is ETA.

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Related Devices (Code: ETA)

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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Official Source

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