The following data is part of a premarket notification filed by Rb Health (us) Llc with the FDA for Durex Patronus Wide.
| Device ID | K213647 |
| 510k Number | K213647 |
| Device Name: | Durex Patronus Wide |
| Classification | Condom |
| Applicant | RB Health (US) LLC 399 Interpace Pkwy Parsippany, NJ 07054 -1133 |
| Contact | Kaitlyn Chan |
| Correspondent | Kaitlyn Chan RB Health (US) LLC 399 Interpace Pkwy Parsippany, NJ 07054 -1133 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-19 |
| Decision Date | 2022-02-17 |