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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, Therapeutic
510(k) Number K954162
Device Name ERGOSEAT SYSTEM
Applicant
Ergo-Air, Inc.
24 Watson St.
Marblehead,  MA  01945
Applicant Contact MARGARET N WAINWRIGHT
Correspondent
Ergo-Air, Inc.
24 Watson St.
Marblehead,  MA  01945
Correspondent Contact MARGARET N WAINWRIGHT
Regulation Number890.5170
Classification Product Code
MOC  
Date Received09/05/1995
Decision Date 10/30/1995
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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