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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 K942920
Device Name MEDAIR EXCEL 2000
Applicant
Medifloat, Inc.
123 Orchard St., Suite 1a
Ormond Beach,  FL  32174
Applicant Contact D. RAY STINSON
Correspondent
Medifloat, Inc.
123 Orchard St., Suite 1a
Ormond Beach,  FL  32174
Correspondent Contact D. RAY STINSON
Regulation Number880.5550
Classification Product Code
FNM  
Date Received06/21/1994
Decision Date 09/19/1994
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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