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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 K913652
Device Name COFFMAN TOMOGRAPH
Applicant
Coffman Dental
12307 Rip Van Winkle
Houston,  TX  77024
Applicant Contact COFFMAN
Correspondent
Coffman Dental
12307 Rip Van Winkle
Houston,  TX  77024
Correspondent Contact COFFMAN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received08/16/1991
Decision Date 10/30/1991
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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