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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 K040622
Device Name FREEDOM HP
Applicant
FREEDOM DESIGNS, INC.
2241 MADERA RD.
SIMI VALLEY,  CA  93065
Applicant Contact GINNY S MALOCO
Correspondent
FREEDOM DESIGNS, INC.
2241 MADERA RD.
SIMI VALLEY,  CA  93065
Correspondent Contact GINNY S MALOCO
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/09/2004
Decision Date 04/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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