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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 K946208
Device Name VOLKER NURSING BED MODEL 2080E & 2090E
Applicant
Volker Healthcare, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact MILTON N BENEKE, JR.
Correspondent
Volker Healthcare, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact MILTON N BENEKE, JR.
Regulation Number880.5100
Classification Product Code
FNL  
Date Received12/21/1994
Decision Date 03/14/1995
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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