Data / Medical devices / United States / Fairhaven Health
Fairhaven Health: FDA-registered device maker in Middletown, CT, United States, 1 510(k) clearance
Fairhaven Health is registered with the FDA (registration 3009171501) in Middletown, CT, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 28, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009171501
- FEI number
- 3005564444
- Address
- 45 Kenneth Dooley Dr, Middletown, CT, United States, 06457
- Owner or operator
- Vital Fairhaven Inc (10037641)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 30, 2017
- Registered through
- 2026
- Brand names listed
- BabyDance Fertility Lubricant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | PEB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 28, 2017 | K162319 | BabyDance Fertility Lubricant | PEB | Substantially Equivalent | Fairhaven Health, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 28, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.