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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 K924130
Device Name COFFMAN IMPLANT TOMOGRAPH
Applicant
COFFMAN DENTAL
12307 RIP VAN WINKLE
HOUSTON,  TX  77024 -4945
Applicant Contact COFFMAN
Correspondent
COFFMAN DENTAL
12307 RIP VAN WINKLE
HOUSTON,  TX  77024 -4945
Correspondent Contact COFFMAN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received08/17/1992
Decision Date 11/27/1992
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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