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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Cast
510(k) Number K864092
Device Name OEC DESIGN ORTHOPEDIC CAST HEEL
Applicant
Military Engineering, Inc.
P.O. Box J 2135 Western
Ave.
Plymouth,  IN  46563
Applicant Contact LEE L HEYDE
Correspondent
Military Engineering, Inc.
P.O. Box J 2135 Western
Ave.
Plymouth,  IN  46563
Correspondent Contact LEE L HEYDE
Regulation Number888.5940
Classification Product Code
LGF  
Date Received10/21/1986
Decision Date 12/16/1986
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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