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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 K083231
Device Name PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT
Applicant
Panthera Production AB
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Applicant Contact STUART R GOLDMAN
Correspondent
Panthera Production AB
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Correspondent Contact STUART R GOLDMAN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/03/2008
Decision Date 01/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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