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FDA 510(k) Application Details - K091875
Device Classification Name
Stimulator, Electro-Acupuncture
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510(K) Number
K091875
Device Name
Stimulator, Electro-Acupuncture
Applicant
MEDEVICE CORPORATION
11 NE 15TH AVE
POMPANO BEACH, FL 33060 US
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TZVI MILSHTEIN
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Regulation Number
000.0000
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Classification Product Code
BWK
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Date Received
06/23/2009
Decision Date
12/07/2009
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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