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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K884308
Device Name MANDIBLE MANIPULATOR
Applicant
Leonard Medical, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Applicant Contact LEONARD J BONNELL
Correspondent
Leonard Medical, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Correspondent Contact LEONARD J BONNELL
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received10/13/1988
Decision Date 03/31/1989
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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