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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K935503
Device Name DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET
Applicant
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Applicant Contact JEANNETTE G CLOUTIER
Correspondent
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Correspondent Contact JEANNETTE G CLOUTIER
Regulation Number884.1730
Classification Product Code
HIF  
Date Received11/16/1993
Decision Date 03/07/1994
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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