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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K021245
Device Name DEGOTZEN SYNCHRO
Applicant
THE GOTZEN GROUP, INC.
30 ALDEN TERRACE
FLANDERS,  NJ  07836
Applicant Contact DONALD R HILL
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number872.1800
Classification Product Code
EHD  
Date Received04/19/2002
Decision Date 05/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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