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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Replacement, Ossicular Prosthesis, Total
510(k) Number K911583
Device Name IONOS(R) OSSICLE 5MM & 7MM
Applicant
Ionos GmbH & Co. KG
D-8031 Seefeld/Obb.
Germany,  DE
Applicant Contact DAGMAR WAIBEL
Correspondent
Ionos GmbH & Co. KG
D-8031 Seefeld/Obb.
Germany,  DE
Correspondent Contact DAGMAR WAIBEL
Regulation Number874.3495
Classification Product Code
ETA  
Date Received04/08/1991
Decision Date 09/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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