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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 K013721
FOIA Releasable 510(k) K013721
Device Name SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
Applicant
CIVCO MEDICAL INSTRUMENTS CO., INC.
102 FIRST ST. SOUTH
KALONA,  IA  52247
Applicant Contact THERESA LEINEN
Correspondent
CIVCO MEDICAL INSTRUMENTS CO., INC.
102 FIRST ST. SOUTH
KALONA,  IA  52247
Correspondent Contact THERESA LEINEN
Regulation Number892.1570
Classification Product Code
ITX  
Date Received11/09/2001
Decision Date 12/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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