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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K001231
Device Name THE KALIX IMPLANT
Applicant
NEWDEAL S.A.
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
NEWDEAL S.A.
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/17/2000
Decision Date 07/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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