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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 K895359
Device Name ADMS MULTIPLANE RECTAL PROBE
Applicant
Avalon Technology Corp.
9174 Castlegate Dr.
Indianapolis,  IN  46256
Applicant Contact SPENCER M VAWTER
Correspondent
Avalon Technology Corp.
9174 Castlegate Dr.
Indianapolis,  IN  46256
Correspondent Contact SPENCER M VAWTER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received08/28/1989
Decision Date 11/22/1989
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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