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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 K944411
Device Name P/2000
Applicant
Plexus Medical
173 E. College St.
Covina,  CA  91723
Applicant Contact J. D RISHALL
Correspondent
Plexus Medical
173 E. College St.
Covina,  CA  91723
Correspondent Contact J. D RISHALL
Regulation Number880.5550
Classification Product Code
FNM  
Date Received09/08/1994
Decision Date 12/27/1994
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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