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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K030307
Device Name DAVOL ARTHROVENT OUTFLOW TUBING
Applicant
DAVOL, INC.
SUBSIDIARY OF C.R. BARD
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact LUCINDA L FOX
Correspondent
N.V. KEMA
P.O. BOX 9035
6800 ET ARNHEM
ARNHEM,  NL
Correspondent Contact MICHELLE WEIDMAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/29/2003
Decision Date 02/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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