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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 K961757
Device Name ECOGEL 100 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 Received05/06/1996
Decision Date 07/25/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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