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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, bone, vertebroplasty
510(k) Number K060300
Device Name CONFIDENCE HIGH VISCOSITY BONE CEMENT
Applicant
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
11 HA'HOSHLIM ST.
HERZLIYA,  IL 46724
Applicant Contact HILA WACHSLER-AVRAHAMI
Correspondent
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
11 HA'HOSHLIM ST.
HERZLIYA,  IL 46724
Correspondent Contact HILA WACHSLER-AVRAHAMI
Regulation Number888.3027
Classification Product Code
NDN  
Date Received02/06/2006
Decision Date 06/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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