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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K901575
Device Name REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD
Applicant
Pioneering Technologies, Inc.
580 Rocque Ave.
Wabasha,  MN  55981
Applicant Contact WOLFE, CPA
Correspondent
Pioneering Technologies, Inc.
580 Rocque Ave.
Wabasha,  MN  55981
Correspondent Contact WOLFE, CPA
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/03/1990
Decision Date 05/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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