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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sound, uterine
510(k) Number K870550
Device Name TEFLON UTERINE SOUND
Applicant
COOK OB/GYN
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact DEXTER J ELKINS
Correspondent
COOK OB/GYN
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact DEXTER J ELKINS
Regulation Number884.4530
Classification Product Code
HHM  
Date Received02/10/1987
Decision Date 03/04/1987
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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