The following data is part of a premarket notification filed by Rb Health (us) Llc with the FDA for Durex Condom With Benzocaine.
| Device ID | K211152 |
| 510k Number | K211152 |
| Device Name: | Durex Condom With Benzocaine |
| Classification | Condom |
| Applicant | RB Health (US) LLC 399 Interpace Parkway Parsippany, NJ 07054 |
| Contact | Kyle Prince |
| Correspondent | Kyle Prince RB Health (US) LLC 399 Interpace Parkway Parsippany, NJ 07054 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-04-19 |
| Decision Date | 2022-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00302340853286 | K211152 | 000 |