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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 K803307
Device Name MATTRESS, AIR FLOATATION, ALTERN. PRESS.
Applicant
Intl. Medical Equipment Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Intl. Medical Equipment Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5550
Classification Product Code
FNM  
Date Received12/30/1980
Decision Date 01/13/1981
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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