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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular, General & Plastic Surgery
510(k) Number K880376
Device Name NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP
Applicant
Genesis Industries, Inc.
214 Mckay Ave.
Spring Valley,  WI  54767
Applicant Contact L ANDERSON,DVM
Correspondent
Genesis Industries, Inc.
214 Mckay Ave.
Spring Valley,  WI  54767
Correspondent Contact L ANDERSON,DVM
Regulation Number878.4200
Classification Product Code
GBS  
Date Received01/27/1988
Decision Date 02/16/1988
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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