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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 K050345
Device Name CIE FOLDAWAY WHEELCHAIR
Applicant
CARLSBAD INTERNATIONAL EXPORT, INC.
1954 KELLOGG AVE.
CARLSBAD,  CA  92008
Applicant Contact LAURA MEYER
Correspondent
CARLSBAD INTERNATIONAL EXPORT, INC.
1954 KELLOGG AVE.
CARLSBAD,  CA  92008
Correspondent Contact LAURA MEYER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/11/2005
Decision Date 03/29/2005
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
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