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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 K990776
Device Name AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
Applicant
Aap Implantate AG
73 Eagles Nest Rd.
Duxbury,  MA  02332
Applicant Contact ELLEN HENKE-KNUPP
Correspondent
Aap Implantate AG
73 Eagles Nest Rd.
Duxbury,  MA  02332
Correspondent Contact ELLEN HENKE-KNUPP
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received03/09/1999
Decision Date 04/29/1999
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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