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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name generator, low voltage, therapeutic x-ray
510(k) Number K895614
Device Name CIVCO LATEX ULTRASOUND SHEATHS
Original Applicant
CIVCO MEDICAL INSTRUMENTS CO., INC.
418 b ave.
kalona,  IA  52247
Original Contact betty forinash
Regulation Number892.5900
Classification Product Code
IYD  
Date Received09/19/1989
Decision Date 12/14/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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