The following data is part of a premarket notification filed by Guy & O'neill, Inc. with the FDA for Ally Warming Liquid Personal Lubricant.
| Device ID | K160717 |
| 510k Number | K160717 |
| Device Name: | Ally Warming Liquid Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | GUY & O'NEILL, INC. 200 INDUSTRIAL DRIVE Fredonia, WI 53021 |
| Contact | Thomas Misgen |
| Correspondent | John Ziobro SPECTRAMEDEX, LLC 3215 GOLF ROAD, #149 Delafield, WI 53018 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-15 |
| Decision Date | 2016-06-14 |
| Summary: | summary |