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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, suction, single patient use, portable, nonpowered
510(k) Number K915536
Device Name DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC
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 Number878.4680
Classification Product Code
GCY  
Date Received12/10/1991
Decision Date 03/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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