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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K963526
Device Name STRAP WEDGE
Applicant
ALIMED, INC.
1200 EAST ST.
DEDHAM,  MA  02026
Applicant Contact DONALD A LINCOLN
Correspondent
ALIMED, INC.
1200 EAST ST.
DEDHAM,  MA  02026
Correspondent Contact DONALD A LINCOLN
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/04/1996
Decision Date 10/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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