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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 K850470
Device Name BED PRODUCTS
Applicant
ABCO DEALERS, INC.
P.O. BOX 17587
6637 NORTH SIDNEY PLACE
MILWAUKEE,  WI  53217
Applicant Contact CHRISTINE NEMETH
Correspondent
ABCO DEALERS, INC.
P.O. BOX 17587
6637 NORTH SIDNEY PLACE
MILWAUKEE,  WI  53217
Correspondent Contact CHRISTINE NEMETH
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received01/28/1985
Decision Date 04/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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