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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 K002205
Device Name CARONY
Applicant
BRUNO INDEPENDENT LIVING AIDS, INC.
1780 EXECUTIVE DR.
OCONOMOWOC,  WI  53066
Applicant Contact RICHARD KELLER
Correspondent
BRUNO INDEPENDENT LIVING AIDS, INC.
1780 EXECUTIVE DR.
OCONOMOWOC,  WI  53066
Correspondent Contact RICHARD KELLER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/21/2000
Decision Date 08/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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