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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 K882154
Device Name HEPAX (TENS)
Applicant
AVL SCIENTIFIC CORP.
33 MANSELL COURT
ROSWELL,  GA  30076 -4807
Applicant Contact ALFRED MAREK
Correspondent
AVL SCIENTIFIC CORP.
33 MANSELL COURT
ROSWELL,  GA  30076 -4807
Correspondent Contact ALFRED MAREK
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/23/1988
Decision Date 09/30/1988
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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