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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 K861073
Device Name AMERICAN ORTHOPAEDIC VACUUM 0295-250
Applicant
Martin Medical
36270 W. 103rd St.
P.O. Box 590
Desoto,  KS  66018
Applicant Contact RANDY KILBURN
Correspondent
Martin Medical
36270 W. 103rd St.
P.O. Box 590
Desoto,  KS  66018
Correspondent Contact RANDY 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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