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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 K963620
Device Name 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
Applicant
9th Wave, Inc.
P.O. Box 1026
Mt Pleasant,  SC  29465
Applicant Contact JEAN ROZINT
Correspondent
9th Wave, Inc.
P.O. Box 1026
Mt Pleasant,  SC  29465
Correspondent Contact JEAN ROZINT
Regulation Number880.5550
Classification Product Code
FNM  
Date Received09/10/1996
Decision Date 01/07/1997
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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