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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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