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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 K963528
Device Name ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)
Applicant
ALIMED, INC.
1200 EAST ST.
DEDHAM,  MA  02026
Applicant Contact DONAL A LINCOLN
Correspondent
ALIMED, INC.
1200 EAST ST.
DEDHAM,  MA  02026
Correspondent Contact DONAL A LINCOLN
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/04/1996
Decision Date 10/29/1996
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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