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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media, electroconductive
510(k) Number K962681
Device Name ECOGEL 300 TENS GEL
Applicant
ECO-MED PHARMACEUTICALS, INC.
6155 TOMKEN ROAD
UNIT 13
MISSISSAUGA, ONTARIO,  CA L4W 1H3
Applicant Contact PAUL L HOOEY
Correspondent
ECO-MED PHARMACEUTICALS, INC.
6155 TOMKEN ROAD
UNIT 13
MISSISSAUGA, ONTARIO,  CA L4W 1H3
Correspondent Contact PAUL L HOOEY
Regulation Number882.1275
Classification Product Code
GYB  
Date Received07/10/1996
Decision Date 10/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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