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FDA 510(k) Application Details - K081943
Device Classification Name
Stimulator, Electro-Acupuncture
More FDA Info for this Device
510(K) Number
K081943
Device Name
Stimulator, Electro-Acupuncture
Applicant
ITO CO., LTD.
1201 RICHARDSON DR., SUITE 140
RICHARDSON, TX 75080 US
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Contact
KENNETH L BLOCK
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
BWK
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More FDA Info for this Product Code
Date Received
07/08/2008
Decision Date
11/24/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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