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FDA 510(k) Application Details - K081247
Device Classification Name
Equipment, Traction, Powered
More FDA Info for this Device
510(K) Number
K081247
Device Name
Equipment, Traction, Powered
Applicant
ITO CO., LTD.
1201 RICHARDSON DR., SUITE 140
RICHARDSON, TX 75080 US
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Contact
KENNETH L BLOCK
Other 510(k) Applications for this Contact
Regulation Number
890.5900
More FDA Info for this Regulation Number
Classification Product Code
ITH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/2008
Decision Date
08/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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