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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K873139
Device Name VARUS AND VALGUS LEG HOLDER
Applicant
Leonard Medical, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Applicant Contact LEONARD J BONNELL
Correspondent
Leonard Medical, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Correspondent Contact LEONARD J BONNELL
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received08/10/1987
Decision Date 09/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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