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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 K014182
Device Name TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS
Applicant
TETRAD CORP.
357 INVERNESS DR. SOUTH,
SUITE A
ENGLEWOOD,  CO  80112
Applicant Contact CHARLES F HOTTINGER
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/20/2001
Decision Date 01/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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