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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 K963360
Device Name MEDLINE BODY HOLDER
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060 -4486
Applicant Contact LARA N SIMMONS
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060 -4486
Correspondent Contact LARA N SIMMONS
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received08/26/1996
Decision Date 10/18/1996
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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