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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K011603
Device Name VHS PEDIATRIC HIP SCREW SYSTEM
Applicant
Walter Abendschein, M.D.
5530 Wisconsin Ave.
Suite 705
Chevy Chase,  MD  20815
Applicant Contact WALTER ABENDSCHEIN
Correspondent
Walter Abendschein, M.D.
5530 Wisconsin Ave.
Suite 705
Chevy Chase,  MD  20815
Correspondent Contact WALTER ABENDSCHEIN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received05/24/2001
Decision Date 08/15/2001
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
Recalls CDRH Recalls
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