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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 K884503
Device Name ULTRASONIC TRANSMISSION GEL
Applicant
Herbert Stanley Co.
8140 N. Ridgeway
Skokie,  IL  60076
Applicant Contact B DEMASI
Correspondent
Herbert Stanley Co.
8140 N. Ridgeway
Skokie,  IL  60076
Correspondent Contact B DEMASI
Regulation Number878.4400
Classification Product Code
JOT  
Date Received10/25/1988
Decision Date 02/13/1989
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
Predetermined Change
Control Plan Authorized		 No
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