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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K915544
Device Name LAPAROSCOPY SCISSORS
Applicant
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Applicant Contact MATTHEW NOWLAND
Correspondent
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Correspondent Contact MATTHEW NOWLAND
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/11/1991
Decision Date 03/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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