The following data is part of a premarket notification filed by Biovo Technologies Ltd. with the FDA for Cuffix.
| Device ID | K192611 |
| 510k Number | K192611 |
| Device Name: | Cuffix |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | Biovo Technologies Ltd. 23 HaMelacha St Rosh Haayin, IL 4809173 |
| Contact | Barbara Sokoletsky |
| Correspondent | Bosmat Friedman ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2020-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017345017 | K192611 | 000 |
| 17290017345038 | K192611 | 000 |