The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Disposineedle Sharps Disposal Unit.
| Device ID | K897095 |
| 510k Number | K897095 |
| Device Name: | DISPOSINEEDLE SHARPS DISPOSAL UNIT |
| Classification | Container, Sharps |
| Applicant | SPECIALITES SEPTODONT WASHINGTON SQUARE 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz SPECIALITES SEPTODONT WASHINGTON SQUARE 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-21 |
| Decision Date | 1990-01-17 |