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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 K954261
Device Name LANDEEZ ALL-TERRAIN WHEELCHAIR
Applicant
Natural Access
2611 Ala Wai Blvd., Suite 1402
Honolulu,  HI  96815
Applicant Contact JOHN EGAM
Correspondent
Natural Access
2611 Ala Wai Blvd., Suite 1402
Honolulu,  HI  96815
Correspondent Contact JOHN EGAM
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/12/1995
Decision Date 10/13/1995
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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