The following data is part of a premarket notification filed by Genesis Industries, Inc. with the FDA for Novo Vivo Model #17140 And #17135.
| Device ID | K880377 |
| 510k Number | K880377 |
| Device Name: | NOVO VIVO MODEL #17140 AND #17135 |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | GENESIS INDUSTRIES, INC. 214 MCKAY AVE. Spring Valley, WI 54767 |
| Contact | Anderson, Dvm |
| Correspondent | Anderson, Dvm GENESIS INDUSTRIES, INC. 214 MCKAY AVE. Spring Valley, WI 54767 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-27 |
| Decision Date | 1988-04-04 |