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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 K852837
Device Name ADVANCED MEDICAL PRODUCTS DR PULSE (TENS)
Applicant
ADVANCED MEDICAL PRODUCTS, INC.
384 PRATT ST.
MERIDEN,  CT  06450
Applicant Contact CHARLES A GARCIA
Correspondent
ADVANCED MEDICAL PRODUCTS, INC.
384 PRATT ST.
MERIDEN,  CT  06450
Correspondent Contact CHARLES A GARCIA
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/02/1985
Decision Date 08/28/1985
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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