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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 K811095
Device Name TRANSCUTANEOUS ELECTRICAL NERVE
Applicant
ACUTEC CORPORATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ACUTEC CORPORATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/21/1981
Decision Date 07/01/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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