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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Partial Ossicular Replacement
510(k) Number K832540
Device Name DRUMTO STAPES PROSTHESIS
Applicant
Humboldt Products
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Humboldt Products
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.3450
Classification Product Code
ETB  
Date Received07/29/1983
Decision Date 01/03/1984
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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