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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 K904418
Device Name ULTRASOUND COUPLING GEL
Applicant
Geno Laboratories
9989 Burbank Dr., Suite 11
Baton Rouge,  LA  70810
Applicant Contact JEFFREY W GENO
Correspondent
Geno Laboratories
9989 Burbank Dr., Suite 11
Baton Rouge,  LA  70810
Correspondent Contact JEFFREY W GENO
Regulation Number878.4400
Classification Product Code
JOT  
Date Received09/27/1990
Decision Date 02/11/1991
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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