The following data is part of a premarket notification filed by Pjur Group Luxembourg Sa with the FDA for Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide And Analyse Me!.
| Device ID | K141913 |
| 510k Number | K141913 |
| Device Name: | PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! |
| Classification | Lubricant, Personal |
| Applicant | PJUR GROUP LUXEMBOURG SA 722 ARJEAN DRIVE Wilmington, NC 28411 |
| Contact | Candace F Cederman |
| Correspondent | Candace F 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 | 2014-07-15 |
| Decision Date | 2015-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40827160112590 | K141913 | 000 |
| 40827160112255 | K141913 | 000 |
| 40827160112248 | K141913 | 000 |
| 40827160112149 | K141913 | 000 |
| 40827160112132 | K141913 | 000 |
| 40827160111920 | K141913 | 000 |
| 40827160111098 | K141913 | 000 |