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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K953293
Device Name PM POSITIONER
Applicant
Jonathan A. Parker, D.D.S.
1801 K St., NW
Washington,  DC  20006
Applicant Contact ROBERT J STEFANI
Correspondent
Jonathan A. Parker, D.D.S.
1801 K St., NW
Washington,  DC  20006
Correspondent Contact ROBERT J STEFANI
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received07/14/1995
Decision Date 09/15/1995
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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