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FDA 510(k) Application Details - K991397
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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510(K) Number
K991397
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
SEIN ELECTRONICS CO., LTD.
1540 BARCLAY BLVD.
BUFFALO GROVE, IL 60089 US
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Contact
S.H. HWANG
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Regulation Number
882.5890
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Classification Product Code
GZJ
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More FDA Info for this Product Code
Date Received
04/21/1999
Decision Date
02/11/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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