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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 K911115
Device Name INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM
Applicant
INTERSON CORP.
16303 PANORAMIC WAY
SAN LEANDRO,  CA  94578
Applicant Contact GARY J ALLSEBROOK
Correspondent
INTERSON CORP.
16303 PANORAMIC WAY
SAN LEANDRO,  CA  94578
Correspondent Contact GARY J ALLSEBROOK
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/07/1991
Decision Date 12/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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