The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Plasti-pore Septal Button.
| Device ID | K781574 |
| 510k Number | K781574 |
| Device Name: | PLASTI-PORE SEPTAL BUTTON |
| Classification | Prosthesis, Nose, Internal |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-18 |
| Decision Date | 1978-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925028432 | K781574 | 000 |
| 00821925017856 | K781574 | 000 |