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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K891457
Device Name DR. VOLKNER'S LAMELLAR TURNING BED(TM)
Applicant
JAMES CONSOLIDATED, INC.
P.O. BOX 3301
WALNUT CREEK,  CA  94598
Applicant Contact BRIAN O JAMES
Correspondent
JAMES CONSOLIDATED, INC.
P.O. BOX 3301
WALNUT CREEK,  CA  94598
Correspondent Contact BRIAN O JAMES
Regulation Number880.5550
Classification Product Code
FNM  
Date Received03/14/1989
Decision Date 06/20/1989
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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