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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 K021748
Device Name ENDIUS ATAVI SYSTEM
Applicant
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE,  MA  02762
Applicant Contact CHRISTINE KUNTZ-NASSIF
Correspondent
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE,  MA  02762
Correspondent Contact CHRISTINE KUNTZ-NASSIF
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/28/2002
Decision Date 06/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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