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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 K002193
Device Name TETRAD TC-C3-ACP
Applicant
TETRAD CORP.
357 INVERNESS DR. SOUTH,
SUITE A
ENGLEWOOD,  CO  80112
Applicant Contact DENNIS R DIETZ
Correspondent
TETRAD CORP.
357 INVERNESS DR. SOUTH,
SUITE A
ENGLEWOOD,  CO  80112
Correspondent Contact DENNIS R DIETZ
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/20/2000
Decision Date 05/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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