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510(k) K970428

REST X SYSTEM by Restxsys — Product Code FNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1997
Date Received
February 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Air Flotation, Alternating Pressure
Device Class
Class II
Regulation Number
880.5550
Review Panel
HO
Submission Type

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