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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 K936102
Device Name DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES
Applicant
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Applicant Contact JEANETTE G CLOUTIER
Correspondent
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Correspondent Contact JEANETTE G CLOUTIER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/22/1993
Decision Date 05/17/1994
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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