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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K990948
Device Name S575 INTRAORAL DOCKING DENTAL CAMERA
Applicant
Sopro
Pl. St. Christophe
Les Accates-La Valentine
Marseille,  FR 13011
Applicant Contact PIERRE MONTILLOT
Correspondent
Sopro
Pl. St. Christophe
Les Accates-La Valentine
Marseille,  FR 13011
Correspondent Contact PIERRE MONTILLOT
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/22/1999
Decision Date 04/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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