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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K955246
Device Name ECOGEL 200 ULTRASOUND 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 Number892.1570
Classification Product Code
ITX  
Date Received11/15/1995
Decision Date 02/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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