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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 K920608
Device Name AMERICA SYSTEM
Applicant
I. Klimov Co.
Rockland Medical Center
4825 N. Broad St.
Philadelphia,  PA  19141
Applicant Contact GRICHENER
Correspondent
I. Klimov Co.
Rockland Medical Center
4825 N. Broad St.
Philadelphia,  PA  19141
Correspondent Contact GRICHENER
Regulation Number888.3030
Classification Product Code
KTT  
Date Received02/11/1992
Decision Date 06/19/1992
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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