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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 K860835
Device Name CEPHALOSTAT
Applicant
Dallas Dental Co.
107 S. Church St.
Mckinney,  TX  75069
Applicant Contact B. G DOUGLAS
Correspondent
Dallas Dental Co.
107 S. Church St.
Mckinney,  TX  75069
Correspondent Contact B. G DOUGLAS
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/05/1986
Decision Date 07/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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