The following data is part of a premarket notification filed by Contipi Medical Ltd. with the FDA for Provate Vaginal Support.
| Device ID | K190277 |
| 510k Number | K190277 |
| Device Name: | ProVate Vaginal Support |
| Classification | Pessary, Vaginal |
| Applicant | ConTIPI Medical Ltd. 2 Alon Ha'Tavor St. Caesarea Industrial Park, POB 3135 Caesarea, IL 3088900 |
| Contact | Tsvia Erlich |
| Correspondent | Jonathan S. Kahan Hogan Lovells US LPP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290019296120 | K190277 | 000 |
| 27290019296113 | K190277 | 000 |
| 27290019296106 | K190277 | 000 |
| 27290019296090 | K190277 | 000 |
| 27290019296083 | K190277 | 000 |
| 27290019296076 | K190277 | 000 |