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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, gel, electrosurgical
510(k) Number K894490
Device Name STERILE ULTRASOUND TRANSMISSION GEL
Applicant
SWEDISH TRADE COUNCIL USA
150 NORTH MICHIGAN AVE.
SUITE 1200
CHICAGO,  IL  60601
Applicant Contact CARL-ANDERS SJOBERG
Correspondent
SWEDISH TRADE COUNCIL USA
150 NORTH MICHIGAN AVE.
SUITE 1200
CHICAGO,  IL  60601
Correspondent Contact CARL-ANDERS SJOBERG
Regulation Number878.4400
Classification Product Code
JOT  
Date Received07/18/1989
Decision Date 10/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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