The following data is part of a premarket notification filed by Ingfertlity, Llc with the FDA for Pre' Vaginal Lubricant.
| Device ID | K051436 |
| 510k Number | K051436 |
| Device Name: | PRE' VAGINAL LUBRICANT |
| Classification | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| Applicant | INGFERTLITY, LLC 17206 S. SPANGLE CREEK ROAD Valleyford, WA 99036 |
| Contact | Dennis Clifton |
| Correspondent | Dennis Clifton INGFERTLITY, LLC 17206 S. SPANGLE CREEK ROAD Valleyford, WA 99036 |
| Product Code | PEB |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2006-10-13 |
| Summary: | summary |