The following data is part of a premarket notification filed by Pjur Group,luxembourg S.a. with the FDA for Pjur(r) Siliconegel, Pjur(r) Basic Personal Glide, Pjur(r) Light, Pjur(r) Med Premium Glide.
| Device ID | K133336 |
| 510k Number | K133336 |
| Device Name: | PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE |
| Classification | Lubricant, Personal |
| Applicant | PJUR GROUP,LUXEMBOURG S.A. 722 ARJEAN DR. Wilmington, NC 28411 |
| Contact | Candace Cederman |
| Correspondent | Candace Cederman PJUR GROUP,LUXEMBOURG S.A. 722 ARJEAN DR. 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 | 2013-10-29 |
| Decision Date | 2014-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40827160112323 | K133336 | 000 |
| 10827160115163 | K133336 | 000 |
| 40827160106292 | K133336 | 000 |
| 40827160111128 | K133336 | 000 |
| 40827160111982 | K133336 | 000 |
| 40827160111999 | K133336 | 000 |
| 40827160112040 | K133336 | 000 |
| 40827160112064 | K133336 | 000 |
| 40827160112071 | K133336 | 000 |
| 40827160112101 | K133336 | 000 |
| 40827160112200 | K133336 | 000 |
| 40827160112224 | K133336 | 000 |
| 40827160112309 | K133336 | 000 |
| 10827160115255 | K133336 | 000 |