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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 K990358
Device Name CROSS SPORT, RIGID WHEELCHAIR
Applicant
TISPORT
1426 EAST THIRD AVE.
KENNEWICK,  WA  99337 -9669
Applicant Contact SANDRA GLADSTONE
Correspondent
TISPORT
1426 EAST THIRD AVE.
KENNEWICK,  WA  99337 -9669
Correspondent Contact SANDRA GLADSTONE
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/05/1999
Decision Date 02/26/1999
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
Recalls CDRH Recalls
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