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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 K861075
Device Name AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202
Applicant
Martin Medical
36270 W. 103rd St.
P.O. Box 590
Desoto,  KS  66018
Applicant Contact RANDY S KILBURN
Correspondent
Martin Medical
36270 W. 103rd St.
P.O. Box 590
Desoto,  KS  66018
Correspondent Contact RANDY S KILBURN
Regulation Number888.5940
Classification Product Code
LGF  
Date Received03/21/1986
Decision Date 03/28/1986
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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