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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 K991799
Device Name DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
Applicant
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact LUCINDA L FOX
Correspondent
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Correspondent Contact LUCINDA L FOX
Regulation Number884.1700
Classification Product Code
HIG  
Date Received05/26/1999
Decision Date 09/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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