The following data is part of a premarket notification filed by Ultrast, Inc. with the FDA for Ultrast Gel.
| Device ID | K211691 |
| 510k Number | K211691 |
| Device Name: | Ultrast Gel |
| Classification | Media, Coupling, Ultrasound |
| Applicant | Ultrast, Inc. 3286 Balsam St Oceanside, NY 11572 |
| Contact | Howard Levine |
| Correspondent | Howard Levine Ultrast, Inc. 3286 Balsam St Oceanside, NY 11572 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-02 |
| Decision Date | 2021-12-22 |