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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K901288
Device Name DAVOL SCOPE IRRIGATION SYSTEM
Applicant
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Applicant Contact ANNETTE M FAGNANT
Correspondent
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Correspondent Contact ANNETTE M FAGNANT
Regulation Number884.1700
Classification Product Code
HIG  
Date Received03/20/1990
Decision Date 10/10/1990
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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