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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 K123975
Device Name QUICKIE & ZIPPIE SERIES
Applicant
SUNRISE MEDICAL
2842 BUSINESS PARK AVE.
FRESNO,  CA  93727 -1328
Applicant Contact LAURIE ROBERTS
Correspondent
SUNRISE MEDICAL
2842 BUSINESS PARK AVE.
FRESNO,  CA  93727 -1328
Correspondent Contact LAURIE ROBERTS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/26/2012
Decision Date 08/16/2013
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
Recalls CDRH Recalls
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