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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 K921722
Device Name BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA
Applicant
Bard Reproductive Systems
200 Ames Pond Dr.
Tewksbury,  MA  01876
Applicant Contact MATTHEW NOWLAND
Correspondent
Bard Reproductive Systems
200 Ames Pond Dr.
Tewksbury,  MA  01876
Correspondent Contact MATTHEW NOWLAND
Regulation Number884.1720
Classification Product Code
HET  
Date Received04/09/1992
Decision Date 05/02/1994
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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