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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name patient bed with canopy/restraints
510(k) Number K113357
Device Name POSEY BED
Original Applicant
5635 peck rd.
arcadia,  CA  91006
Original Contact bonnie bishop
Regulation Number880.6760
Classification Product Code
Date Received11/14/2011
Decision Date 03/21/2012
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