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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cushion, Flotation
510(k) Number K945667
Device Name MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION
Applicant
Micos Medical Systems
7550 Bendere
Hickory Corners,  MI  49060
Applicant Contact JIM TAPPELL
Correspondent
Micos Medical Systems
7550 Bendere
Hickory Corners,  MI  49060
Correspondent Contact JIM TAPPELL
Regulation Number890.3175
Classification Product Code
KIC  
Date Received11/17/1994
Decision Date 02/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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