The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Centrix Ribbon Tubes.
| Device ID | K853282 |
| 510k Number | K853282 |
| Device Name: | CENTRIX RIBBON TUBES |
| Classification | Syringe, Restorative And Impression Material |
| Applicant | CENTRIX, INC. 724 HONEYSPOT RD. Stratford, CT 06497 |
| Contact | John Discko |
| Correspondent | John Discko CENTRIX, INC. 724 HONEYSPOT RD. Stratford, CT 06497 |
| Product Code | EID |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-08-23 |