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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cephalometer
510(k) Number K944162
Device Name DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM
Applicant
Teledyne Water Pik
1730 E. Prospect Rd.
Fort Collins,  CO  80525 -1310
Applicant Contact CODY RILEY
Correspondent
Teledyne Water Pik
1730 E. Prospect Rd.
Fort Collins,  CO  80525 -1310
Correspondent Contact CODY RILEY
Regulation Number872.1830
Classification Product Code
EAG  
Date Received08/26/1994
Decision Date 11/29/1994
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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