The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Pappas Tri-flange Ventilation Tube.
| Device ID | K895242 |
| 510k Number | K895242 |
| Device Name: | PAPPAS TRI-FLANGE VENTILATION TUBE |
| Classification | Tube, Tympanostomy |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-21 |
| Decision Date | 1989-11-17 |