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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 K072153
Device Name QUICKIE QX MANUAL FOLDING WHEELCHAIR
Applicant
SUNRISE MEDICAL, INC.
2842 BUSINESS PARK AVE.
FRESNO,  CA  93727
Applicant Contact JOSEPH E OLSAVSKY
Correspondent
SUNRISE MEDICAL, INC.
2842 BUSINESS PARK AVE.
FRESNO,  CA  93727
Correspondent Contact JOSEPH E OLSAVSKY
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/03/2007
Decision Date 09/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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