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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 K780469
Device Name PANORAMIC X-RAY, DENTAL
Applicant
Den-Tal-Ez Mfg Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Den-Tal-Ez Mfg Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/22/1978
Decision Date 04/10/1978
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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