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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, carbon-dioxide, uterotubal (and accessories)
510(k) Number K891290
Device Name SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
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 Number884.1300
Classification Product Code
HES  
Date Received03/10/1989
Decision Date 05/23/1989
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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