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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 K991236
Device Name GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,
Applicant
CIVCO Medical Instruments Co., Inc.
102 First St. S.
Kalona,  IA  52247
Applicant Contact J. WILLIAM JONES
Correspondent
CIVCO Medical Instruments Co., Inc.
102 First St. S.
Kalona,  IA  52247
Correspondent Contact J. WILLIAM JONES
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/12/1999
Decision Date 06/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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