The following data is part of a premarket notification filed by United Consortium with the FDA for Jo Gelato Flavored Personal Lubricants.
| Device ID | K172447 |
| 510k Number | K172447 |
| Device Name: | JO Gelato Flavored Personal Lubricants |
| 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 | 2017-08-14 |
| Decision Date | 2017-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B362701271 | K172447 | 000 |
| B362410201 | K172447 | 000 |
| B362410211 | K172447 | 000 |
| B362410221 | K172447 | 000 |
| B362410231 | K172447 | 000 |
| B362410241 | K172447 | 000 |
| B362440201 | K172447 | 000 |
| B362440211 | K172447 | 000 |
| B362440221 | K172447 | 000 |
| B362440231 | K172447 | 000 |
| B362440241 | K172447 | 000 |
| B362701251 | K172447 | 000 |
| B362410220 | K172447 | 000 |