The following data is part of a premarket notification filed by Pjur Group Luxembourg Sa with the FDA for Pjur Woman Aloe, Pjur Analyse Me! Water-based, Pjur Back Door Water-based, Pjur Med Moisturising Glide,pjur Med Natural Glide, We-vibe Lube Made By Pjur.
| Device ID | K200527 |
| 510k Number | K200527 |
| Device Name: | Pjur WOMAN Aloe, Pjur Analyse Me! Water-based, Pjur BACK DOOR Water-based, Pjur Med Moisturising Glide,pjur Med NATURAL Glide, We-Vibe Lube Made By Pjur |
| 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 | 2020-03-02 |
| Decision Date | 2021-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827160115071 | K200527 | 000 |
| 10827160115040 | K200527 | 000 |
| 10827160115002 | K200527 | 000 |
| 10827160114999 | K200527 | 000 |
| 10827160115187 | K200527 | 000 |
| 10827160116290 | K200527 | 000 |
| 10827160116276 | K200527 | 000 |
| 00827160114350 | K200527 | 000 |
| 10827160116788 | K200527 | 000 |