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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 K861678
Device Name COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED
Applicant
Sierra Corp.
P.O. Box 806
Fort Smith,  AR  72902
Applicant Contact WILLIAM B STELL
Correspondent
Sierra Corp.
P.O. Box 806
Fort Smith,  AR  72902
Correspondent Contact WILLIAM B STELL
Regulation Number880.5120
Classification Product Code
FNJ  
Date Received05/01/1986
Decision Date 05/08/1986
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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