The following data is part of a premarket notification filed by Contipi Ltd. with the FDA for Tipi Otc.
| Device ID | K131198 |
| 510k Number | K131198 |
| Device Name: | TIPI OTC |
| Classification | Pessary, Vaginal |
| Applicant | CONTIPI LTD. 555 THIRTEENTH ST NW Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan CONTIPI LTD. 555 THIRTEENTH ST 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 | 2013-04-26 |
| Decision Date | 2013-08-27 |
| Summary: | summary |