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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K920234
Device Name DAVOL LAPAROSCOPIC DISSECTORS
Applicant
C.R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Applicant Contact MARY M MCNAMARA
Correspondent
C.R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Correspondent Contact MARY M MCNAMARA
Regulation Number884.1720
Classification Product Code
HET  
Date Received01/17/1992
Decision Date 02/05/1993
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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