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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 K915533
Device Name QUICKIE CARBON WHEELCHAIR
Applicant
Sunrise Medical Quickie Designs, Inc.
2842 Business Park Ave.
Fresno,  CA  93727
Applicant Contact PAT SPINK
Correspondent
Sunrise Medical Quickie Designs, Inc.
2842 Business Park Ave.
Fresno,  CA  93727
Correspondent Contact PAT SPINK
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/10/1991
Decision Date 01/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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