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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chisel, Osteotome, Surgical
510(k) Number K760959
Device Name SURGICAL CHISEL
Applicant
American Safety Equipment Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Safety Equipment Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4565
Classification Product Code
EMM  
Date Received11/01/1976
Decision Date 11/15/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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