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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 K040612
Device Name SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
Applicant
Disc-O-Tech Medical Technologies, Ltd.
3 Hasadnaot St.
Herzliya,  IL 46728
Applicant Contact YAEL RUBIN
Correspondent
Disc-O-Tech Medical Technologies, Ltd.
3 Hasadnaot St.
Herzliya,  IL 46728
Correspondent Contact YAEL RUBIN
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HXG  
Date Received03/08/2004
Decision Date 06/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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