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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 K872519
Device Name STERILIZED OMNI GEL
Applicant
Echo Ultrasound
Post Office Box 552
Lewistown,  PA  17044
Applicant Contact DAVID SZCZUPAKOWSKI
Correspondent
Echo Ultrasound
Post Office Box 552
Lewistown,  PA  17044
Correspondent Contact DAVID SZCZUPAKOWSKI
Regulation Number878.4400
Classification Product Code
JOT  
Date Received06/25/1987
Decision Date 08/03/1987
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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