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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K002856
Device Name AT3C70 TRANSDUCER
Applicant
Sonora Medical Systems
7992 Castleway Dr.
Indianpolis,  IN  46250
Applicant Contact COLLEEN HITTLE
Correspondent
Sonora Medical Systems
7992 Castleway Dr.
Indianpolis,  IN  46250
Correspondent Contact COLLEEN HITTLE
Regulation Number892.1570
Classification Product Code
ITX  
Date Received09/13/2000
Decision Date 04/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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