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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K002184
Device Name COD COMPRESSION OSTEOTOMY DEVICE
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
HRS  
Date Received07/19/2000
Decision Date 11/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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