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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 K951026
Device Name DAVOL ARTHRO-FLO 3
Applicant
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Applicant Contact DORIS PETERKIN
Correspondent
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Correspondent Contact DORIS PETERKIN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/06/1995
Decision Date 06/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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