The following data is part of a premarket notification filed by Pjur Group Luxembourg Sa with the FDA for Pjur Woman Nude Pjur Med Sensitive Glide.
| Device ID | K200730 |
| 510k Number | K200730 |
| Device Name: | Pjur WOMAN Nude Pjur Med SENSITIVE Glide |
| Classification | Lubricant, Personal |
| Applicant | pjur Group Luxembourg SA 87 Esplanade De La Moselle Wasserbillig, LU L-6637 |
| Contact | Andrea Giebel |
| Correspondent | Candace Cederman Candace F. Cederman 722 Arjean Drive Wilmington, NC 28411 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-20 |
| Decision Date | 2020-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827160115033 | K200730 | 000 |
| 10827160115170 | K200730 | 000 |
| 10827160115262 | K200730 | 000 |
| 10827160116283 | K200730 | 000 |
| 00827160114367 | K200730 | 000 |