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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K972230
Device Name QUICKIE P90 SERIES
Applicant
Quickie Designs, Inc.
2842 Business Park Ave.
Fresno,  CA  93727
Applicant Contact REBECCA ANDERSEN
Correspondent
Quickie Designs, Inc.
2842 Business Park Ave.
Fresno,  CA  93727
Correspondent Contact REBECCA ANDERSEN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/13/1997
Decision Date 12/02/1997
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
Predetermined Change
Control Plan Authorized		 No
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