The following data is part of a premarket notification filed by Inter-med, Inc. with the FDA for Ps System.
| Device ID | K211721 |
| 510k Number | K211721 |
| Device Name: | PS System |
| Classification | Handpiece, Air-powered, Root Canal Irrigation |
| Applicant | Inter-Med, INC. 2200 South Street Racine, WI 53404 |
| Contact | Brett Arand |
| Correspondent | Brett Arand Inter-Med, INC. 2200 South Street Racine, WI 53404 |
| Product Code | NYL |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-04 |
| Decision Date | 2021-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818207024388 | K211721 | 000 |
| 10818207024371 | K211721 | 000 |
| 10818207024364 | K211721 | 000 |