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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
Predetermined Change
Control Plan Authorized		 No
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