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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Laparoscopic, Unipolar (And Accessories)
510(k) Number K921405
Device Name DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP
Applicant
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Applicant Contact ANNETTE M FAGNANT
Correspondent
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Correspondent Contact ANNETTE M FAGNANT
Regulation Number884.4160
Classification Product Code
HFG  
Subsequent Product Code
HET  
Date Received03/24/1992
Decision Date 03/25/1994
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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