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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 K864108
Device Name PUSH CUSH
Applicant
Medical Industries America, Inc.
6a Nelson St.
Annandale N.Sw
Australia 2038,  AU
Applicant Contact RUSSELL F BIRD
Correspondent
Medical Industries America, Inc.
6a Nelson St.
Annandale N.Sw
Australia 2038,  AU
Correspondent Contact RUSSELL F BIRD
Regulation Number890.3175
Classification Product Code
KIC  
Date Received10/21/1986
Decision Date 11/14/1986
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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