The following data is part of a premarket notification filed by Genesis Industries, Inc. with the FDA for Novo Vivo Suction Catheter Vessel W/mucose Trap.
| Device ID | K880376 |
| 510k Number | K880376 |
| Device Name: | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | GENESIS INDUSTRIES, INC. 214 MCKAY AVE. Spring Valley, WI 54767 |
| Contact | L Anderson,dvm |
| Correspondent | L Anderson,dvm GENESIS INDUSTRIES, INC. 214 MCKAY AVE. Spring Valley, WI 54767 |
| Product Code | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-27 |
| Decision Date | 1988-02-16 |