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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 K925571
Device Name OTI EUROPEAN COMPRESSION SYSTEM
Applicant
Osteo-Technology Intl., Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Osteo-Technology Intl., Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Correspondent Contact SAM SON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/03/1992
Decision Date 07/13/1993
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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