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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Manual
510(k) Number K852890
Device Name AM FAB SIDE RAILS MODEL 5000
Applicant
Am Fab, Inc.
2525 Miller Rd.
Kalamazoo,  MI  49001
Applicant Contact JAY SMART
Correspondent
Am Fab, Inc.
2525 Miller Rd.
Kalamazoo,  MI  49001
Correspondent Contact JAY SMART
Regulation Number880.5120
Classification Product Code
FNJ  
Date Received07/09/1985
Decision Date 07/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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