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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, transcutaneous, for pain relief
510(k) Number K013532
Device Name ULTRASTIM KIT
Applicant
AXELGAARD MFG. CO., LTD.
1667 S. MISSION RD.
FALLBROOK,  CA  92028 -4115
Applicant Contact DAN JEFFERY
Correspondent
AXELGAARD MFG. CO., LTD.
1667 S. MISSION RD.
FALLBROOK,  CA  92028 -4115
Correspondent Contact DAN JEFFERY
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
GXY   IQE  
Date Received10/17/2001
Decision Date 08/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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