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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K860072
Device Name JUERGENS SELF RELIANT WHEELCHAIR
Applicant
E.H. Juergens, Inc.
216 Green Bay Rd., Suite 208
Thiensville,  WI  53092
Applicant Contact EUGENE H JUERGENS
Correspondent
E.H. Juergens, Inc.
216 Green Bay Rd., Suite 208
Thiensville,  WI  53092
Correspondent Contact EUGENE H JUERGENS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/06/1986
Decision Date 01/13/1986
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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