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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 K871051
Device Name FIAD EXPLOR-X; MODEL 70 KVP
Applicant
United States Dental
922 E. Old Willow Rd.
Suite 105
Prospect Hts.,  IL  60070
Applicant Contact AL SOSA
Correspondent
United States Dental
922 E. Old Willow Rd.
Suite 105
Prospect Hts.,  IL  60070
Correspondent Contact AL SOSA
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/17/1987
Decision Date 05/04/1987
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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