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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sampler, amniotic fluid (amniocentesis tray)
510(k) Number K892846
Device Name ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
Applicant
COOK OB/GYN
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
COOK OB/GYN
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number884.1550
Classification Product Code
HIO  
Date Received04/18/1989
Decision Date 07/14/1989
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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