The following data is part of a premarket notification filed by United Consortium with the FDA for Silicone Personal Lubricant, All-in-one.
| Device ID | K180083 |
| 510k Number | K180083 |
| Device Name: | Silicone Personal Lubricant, ALL-IN-ONE |
| Classification | Lubricant, Personal |
| Applicant | United Consortium 29000 N. Hancock Pkwy. Valencia, CA 91355 |
| Contact | Stephanie Morris |
| Correspondent | Stephanie Morris United Consortium 29000 N. Hancock Pkwy. Valencia, CA 91355 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-11 |
| Decision Date | 2018-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B362400231 | K180083 | 000 |
| 10796494001209 | K180083 | 000 |
| 10796494001841 | K180083 | 000 |
| 10796494000462 | K180083 | 000 |
| 10796494000479 | K180083 | 000 |
| 10796494000486 | K180083 | 000 |
| 10796494000493 | K180083 | 000 |
| 10796494000103 | K180083 | 000 |
| 10796494000134 | K180083 | 000 |
| 10796494000301 | K180083 | 000 |
| 10796494000318 | K180083 | 000 |
| 10796494000325 | K180083 | 000 |
| 10796494000332 | K180083 | 000 |
| 10796494000349 | K180083 | 000 |
| B362101451 | K180083 | 000 |
| 10796494001193 | K180083 | 000 |