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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 K945629
Device Name MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS
Applicant
Micos Medical Systems
7550 Bendere
Hickory Corners,  MI  49060
Applicant Contact JIM TAPPEL
Correspondent
Micos Medical Systems
7550 Bendere
Hickory Corners,  MI  49060
Correspondent Contact JIM TAPPEL
Regulation Number880.5550
Classification Product Code
FNM  
Date Received11/16/1994
Decision Date 04/14/1995
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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