The following data is part of a premarket notification filed by River Medical, Inc. with the FDA for Grommet Style Venturi.
| Device ID | K904597 |
| 510k Number | K904597 |
| Device Name: | GROMMET STYLE VENTURI |
| Classification | Tube, Tympanostomy |
| Applicant | RIVER MEDICAL, INC. P.O.BOX 30517 Memphis, TN 38130 |
| Contact | W Murray |
| Correspondent | W Murray RIVER MEDICAL, INC. P.O.BOX 30517 Memphis, TN 38130 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-10 |
| Decision Date | 1991-01-28 |