The following data is part of a premarket notification filed by Ingfertility, Llc with the FDA for Pre-va Vaginal Lubricant.
| Device ID | K072741 |
| 510k Number | K072741 |
| Device Name: | PRE-VA VAGINAL LUBRICANT |
| Classification | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| Applicant | INGFERTILITY, LLC 17206 S. SPANGLE CREEK RD. Valleyford, WA 99036 |
| Contact | Dennis Clifton |
| Correspondent | Dennis Clifton INGFERTILITY, LLC 17206 S. SPANGLE CREEK RD. 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 | 2007-09-27 |
| Decision Date | 2008-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00055114999061 | K072741 | 000 |
| 00050428285183 | K072741 | 000 |
| 00855114000992 | K072741 | 000 |
| 00855114000961 | K072741 | 000 |