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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K963589
Device Name VAIL 3000 BED ENCLOSURE
Applicant
Vail Products, Inc.
235 First St.
Toledo,  OH  43605
Applicant Contact NANCY VAIL
Correspondent
Vail Products, Inc.
235 First St.
Toledo,  OH  43605
Correspondent Contact NANCY VAIL
Regulation Number880.5100
Classification Product Code
FNL  
Date Received09/09/1996
Decision Date 04/21/1997
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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