The following data is part of a premarket notification filed by Rb Health (us) Llc with the FDA for Durex Penck Standard, Durex Penck Xl.
| Device ID | K200672 |
| 510k Number | K200672 |
| Device Name: | Durex Penck Standard, Durex Penck XL |
| 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 | No |
| Date Received | 2020-03-13 |
| Decision Date | 2020-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10302340876428 | K200672 | 000 |
| 99067981087981 | K200672 | 000 |
| 77067981087972 | K200672 | 000 |
| 10302340876466 | K200672 | 000 |
| 10302340876473 | K200672 | 000 |
| 10302340876480 | K200672 | 000 |
| 40302340876498 | K200672 | 000 |
| 10302340995662 | K200672 | 000 |
| 10302340010051 | K200672 | 000 |
| 10067981087977 | K200672 | 000 |
| 20067981087981 | K200672 | 000 |
| 20067981087998 | K200672 | 000 |
| 00302340876483 | K200672 | 000 |