The following data is part of a premarket notification filed by L.c.c. Pjur Group Germany with the FDA for Pjur Eros Water Formulation.
| Device ID | K010199 |
| 510k Number | K010199 |
| Device Name: | PJUR EROS WATER FORMULATION |
| Classification | Lubricant, Personal |
| Applicant | L.C.C. PJUR GROUP GERMANY 65 BANK ST. SUITE #9 New York, NY 10014 |
| Contact | Richard Harris |
| Correspondent | Richard Harris L.C.C. PJUR GROUP GERMANY 65 BANK ST. SUITE #9 New York, NY 10014 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40827160112019 | K010199 | 000 |
| 40827160110350 | K010199 | 000 |
| 40827160110329 | K010199 | 000 |
| 40827160110107 | K010199 | 000 |
| 40827160110091 | K010199 | 000 |
| 40827160110084 | K010199 | 000 |
| 40827160106315 | K010199 | 000 |
| 40827160106308 | K010199 | 000 |
| 40827160100252 | K010199 | 000 |
| 10827160114296 | K010199 | 000 |
| 10827160114289 | K010199 | 000 |
| 10827160114739 | K010199 | 000 |
| 00827160115029 | K010199 | 000 |
| 10827160115439 | K010199 | 000 |
| 40827160111142 | K010199 | 000 |
| 40827160111456 | K010199 | 000 |
| 40827160111463 | K010199 | 000 |
| 40827160114211 | K010199 | 000 |
| 00827160113216 | K010199 | 000 |
| 40827160112712 | K010199 | 000 |
| 40827160112606 | K010199 | 000 |
| 40827160112279 | K010199 | 000 |
| 40827160112262 | K010199 | 000 |
| 40827160112231 | K010199 | 000 |
| 40827160112163 | K010199 | 000 |
| 40827160112156 | K010199 | 000 |
| 40827160112125 | K010199 | 000 |
| 40827160112118 | K010199 | 000 |
| 40827160112088 | K010199 | 000 |
| 40827160112026 | K010199 | 000 |
| 10827160115422 | K010199 | 000 |