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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 K133855
Device Name BREEZY ELEGANCE
Applicant
SUNRISE MEDICAL (US) LLC
2842 BUSINESS PARK AVE
FRESNO,  CA  93727
Applicant Contact LAURIE H ROBERTS
Correspondent
SUNRISE MEDICAL (US) LLC
2842 BUSINESS PARK AVE
FRESNO,  CA  93727
Correspondent Contact LAURIE H ROBERTS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/19/2013
Decision Date 01/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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