The following data is part of a premarket notification filed by Pjur Group Luxembourg Sa with the FDA for Pjur Original, Pjur Woman, Pjur Man Extreme Glide.
| Device ID | K133233 |
| 510k Number | K133233 |
| Device Name: | PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE |
| Classification | Lubricant, Personal |
| Applicant | PJUR GROUP LUXEMBOURG SA 722 ARJEAN DRIVE Wilmington, NC 28411 |
| Contact | Candace Cederman |
| Correspondent | Candace Cederman PJUR GROUP LUXEMBOURG SA 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 | 2013-10-21 |
| Decision Date | 2014-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40827160112316 | K133233 | 000 |
| 10827160114920 | K133233 | 000 |
| 40827160100016 | K133233 | 000 |
| 40827160100092 | K133233 | 000 |
| 40827160100757 | K133233 | 000 |
| 40827160100771 | K133233 | 000 |
| 40827160100795 | K133233 | 000 |
| 40827160101853 | K133233 | 000 |
| 40827160101860 | K133233 | 000 |
| 40827160104779 | K133233 | 000 |
| 40827160107282 | K133233 | 000 |
| 40827160112095 | K133233 | 000 |
| 40827160112217 | K133233 | 000 |
| 40827160112293 | K133233 | 000 |
| 00827160115012 | K133233 | 000 |