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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bur, ear, nose and throat
510(k) Number K792028
Device Name OTOTOME BUR
Applicant
AMERICAN STERILIZER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN STERILIZER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4140
Classification Product Code
EQJ  
Date Received10/09/1979
Decision Date 10/26/1979
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
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