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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K872525
Device Name A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH
Applicant
M.C. Johnson Co., Inc.
758 Main St.
Leominster,  MA  01453
Applicant Contact MELISSA C JOHNSON
Correspondent
M.C. Johnson Co., Inc.
758 Main St.
Leominster,  MA  01453
Correspondent Contact MELISSA C JOHNSON
Regulation Number892.1680
Classification Product Code
KPR  
Date Received06/25/1987
Decision Date 02/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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