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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
Predetermined Change
Control Plan Authorized		 No
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