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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 K833964
Device Name PEGASUS MATTRESS
Applicant
Dermalex Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dermalex Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5550
Classification Product Code
FNM  
Date Received11/16/1983
Decision Date 01/30/1984
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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