The following data is part of a premarket notification filed by One with the FDA for One Personal Lubricant (silicone).
| Device ID | K110690 |
| 510k Number | K110690 |
| Device Name: | ONE PERSONAL LUBRICANT (SILICONE) |
| Classification | Lubricant, Personal |
| Applicant | ONE 12 CHANNEL STREET Boston, MA 02210 |
| Contact | Sharon Pietila |
| Correspondent | Sharon Pietila ONE 12 CHANNEL STREET Boston, MA 02210 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-11 |
| Decision Date | 2012-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600001089 | K110690 | 000 |