The following data is part of a premarket notification filed by Good Clean Love with the FDA for Restore Moisturizing Vaginal Lubricant.
| Device ID | K162207 |
| 510k Number | K162207 |
| Device Name: | Restore Moisturizing Vaginal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | Good Clean Love 207 West 5th Avenue Eugene, OR 97401 |
| Contact | Wendy Strgar |
| Correspondent | Steve Hesler S. Hesler Compliance Engineering 2602 5th Ave West Linn, OR 97068 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-05 |
| Decision Date | 2017-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893268000222 | K162207 | 000 |
| 00893268000710 | K162207 | 000 |