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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K833598
Device Name LEBLOND DIAMOND DENTAL BUR
Applicant
A & M Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
A & M Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3240
Classification Product Code
EJL  
Date Received10/12/1983
Decision Date 12/29/1983
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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