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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K890433
Device Name IMPLANT PARALLELING DEVICE (I.P.D.)
Applicant
J.E. Josephson, D.M.D.
1775 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact KNABLE GOTTS
Correspondent
J.E. Josephson, D.M.D.
1775 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact KNABLE GOTTS
Regulation Number872.4200
Classification Product Code
EFB  
Date Received01/27/1989
Decision Date 06/16/1989
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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