The following data is part of a premarket notification filed by Fairhaven Health, Llc with the FDA for Babydance Fertility Lubricant.
| Device ID | K162319 |
| 510k Number | K162319 |
| Device Name: | BabyDance Fertility Lubricant |
| Classification | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| Applicant | Fairhaven Health, LLC 1410 11th St Bellingham, WA 98225 |
| Contact | Suzanne Munson |
| Correspondent | Suzanne Munson Fairhaven Health, LLC 1410 11th St Bellingham, WA 98225 |
| Product Code | PEB |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-19 |
| Decision Date | 2017-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00896593002497 | K162319 | 000 |
| 00896593002480 | K162319 | 000 |
| 00896593002220 | K162319 | 000 |