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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 K901217
Device Name TRIA-SONIC ULTRA SOUND TRANSMISSION GEL
Applicant
H & P Industries, Inc.
9640 S 60th St.
Franklin,  WI  53132
Applicant Contact GEORGE HORVAT
Correspondent
H & P Industries, Inc.
9640 S 60th St.
Franklin,  WI  53132
Correspondent Contact GEORGE HORVAT
Regulation Number878.4400
Classification Product Code
JOT  
Date Received03/13/1990
Decision Date 06/22/1990
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
Predetermined Change
Control Plan Authorized		 No
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