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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 K890869
Device Name BARD HYSTEROSALPINGOGRAPHY CATHETERS
Applicant
C.R. Bard, Inc.
5 Federal St.
P.O. Box 5069
Billerica,  MA  01822
Applicant Contact ERNEST MANFREDO
Correspondent
C.R. Bard, Inc.
5 Federal St.
P.O. Box 5069
Billerica,  MA  01822
Correspondent Contact ERNEST MANFREDO
Regulation Number884.1300
Classification Product Code
HES  
Date Received02/21/1989
Decision Date 04/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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