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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 K923067
Device Name SENS-A-RAY
Applicant
Regam Medical Systems
631 Monytoyal Blvd.
North Vancouver, B.C.
V7r 2g2 Canada,  CA
Correspondent
Regam Medical Systems
631 Monytoyal Blvd.
North Vancouver, B.C.
V7r 2g2 Canada,  CA
Regulation Number872.1800
Classification Product Code
EHD  
Date Received06/25/1992
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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