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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 K897028
Device Name LINCOLN MILLS FOOT AND LEG HOLDER
Applicant
Lincoln Mills, Inc.
Medical Products Group
510 Rte. 304
New City,  NY  10956
Applicant Contact LAICO, MD
Correspondent
Lincoln Mills, Inc.
Medical Products Group
510 Rte. 304
New City,  NY  10956
Correspondent Contact LAICO, MD
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received12/19/1989
Decision Date 01/12/1990
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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