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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 K963185
Device Name ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER
Applicant
Electronic Control Concepts
213 Chas. Hommel Rd.
Saugerties,  NY  12477
Applicant Contact GARY BISCHOFF
Correspondent
Electronic Control Concepts
213 Chas. Hommel Rd.
Saugerties,  NY  12477
Correspondent Contact GARY BISCHOFF
Regulation Number872.1800
Classification Product Code
EHD  
Date Received08/14/1996
Decision Date 10/02/1996
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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