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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 E. St.
Dedham,  MA  02026
Applicant Contact DONAL A LINCOLN
Correspondent
Alimed, Inc.
1200 E. 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
Predetermined Change
Control Plan Authorized		 No
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