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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 K874877
Device Name PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER
Applicant
Pegasus Airwave, Inc.
Portsmouth Enterprise Centre
Quartremaine Rd., Portsmouth
Hants Po35qt, England,  GB
Applicant Contact WELCH
Correspondent
Pegasus Airwave, Inc.
Portsmouth Enterprise Centre
Quartremaine Rd., Portsmouth
Hants Po35qt, England,  GB
Correspondent Contact WELCH
Regulation Number880.5550
Classification Product Code
FNM  
Date Received11/13/1987
Decision Date 02/22/1988
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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