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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 K911205
Device Name ARTHROSCOPY INSTRUMENT CANNULA
Applicant
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Applicant Contact LEO BASTA
Correspondent
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Correspondent Contact LEO BASTA
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/19/1991
Decision Date 06/17/1991
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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