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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 K970428
Device Name REST X SYSTEM
Applicant
RESTXSYS
19636 CLUB HOUSE RD.
SUITE 120
GAITHERSBURG,  MD  20879
Applicant Contact YOAV GERSHONI
Correspondent
RESTXSYS
19636 CLUB HOUSE RD.
SUITE 120
GAITHERSBURG,  MD  20879
Correspondent Contact YOAV GERSHONI
Regulation Number880.5550
Classification Product Code
FNM  
Date Received02/04/1997
Decision Date 05/14/1997
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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