The following data is part of a premarket notification filed by Sims Portex Ltd. with the FDA for Portex Ring Pessary Pvc-non Sterile; Portex Ring Pessary Polythene- Non Sterile.
| Device ID | K012277 |
| 510k Number | K012277 |
| Device Name: | PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE |
| Classification | Pessary, Vaginal |
| Applicant | SIMS PORTEX LTD. HYTHE Hythe, Kent, GB Ct 21 6jl |
| Contact | Steven Ogilvie |
| Correspondent | Steven Ogilvie SIMS PORTEX LTD. HYTHE Hythe, Kent, GB Ct 21 6jl |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-19 |
| Decision Date | 2002-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937020889 | K012277 | 000 |
| 20888937020742 | K012277 | 000 |
| 20888937020759 | K012277 | 000 |
| 20888937020766 | K012277 | 000 |
| 20888937020773 | K012277 | 000 |
| 20888937020780 | K012277 | 000 |
| 20888937020797 | K012277 | 000 |
| 20888937020803 | K012277 | 000 |
| 20888937020810 | K012277 | 000 |
| 20888937020827 | K012277 | 000 |
| 20888937020834 | K012277 | 000 |
| 20888937020841 | K012277 | 000 |
| 20888937020858 | K012277 | 000 |
| 20888937020865 | K012277 | 000 |
| 20888937020872 | K012277 | 000 |
| 20888937020735 | K012277 | 000 |