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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name imager, ultrasonic obstetric-gynecologic
510(k) Number K851902
Device Name MODEL U-1000 ULTRASONIC SCANNER
Applicant
FUKUDA DENSHI USA, INC.
12539 130TH LN. NE
KIRKLAND,  WA  98034 -
Applicant Contact DON ANDRESEN
Correspondent
FUKUDA DENSHI USA, INC.
12539 130TH LN. NE
KIRKLAND,  WA  98034 -
Correspondent Contact DON ANDRESEN
Regulation Number884.2225
Classification Product Code
HEM  
Date Received04/30/1985
Decision Date 09/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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