The following data is part of a premarket notification filed by Vonco Products with the FDA for Enteraloc Flow.
| Device ID | K210971 |
| 510k Number | K210971 |
| Device Name: | EnteraLoc Flow |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Vonco Products 10826 250th Avenue Trevor, WI 53179 |
| Contact | Christie Marr |
| Correspondent | Christie Marr Vonco Products 10826 250th Avenue Trevor, WI 53179 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-31 |
| Decision Date | 2021-08-18 |