510(k) K162319
- Device
- BabyDance Fertility Lubricant
- Applicant
- Fairhaven Health, LLC
- 510(k) number
- K162319
- Product code
- PEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-28
- Date received
- 2016-08-19
- Regulation
- 884.5300
- Classification name
- Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Suzanne Munson
- Address
- 1410 11th St. Bellingham WA US 98225 98225
FDA Registration Numbers#
- 3040301765
- 3007067755
- 3005630901
- 3010852191
- 3009171501
- 3021350800
- 2280705
- 3013395518
- 3012725363
- 1063707
- 3003231640
Source Documents#
Other 510(k) Records For Product Code PEB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212885 | Actively Trying Personal Lubricant Rose Scented | CC Wellness, LLC | 2022-02-11 |
| K212705 | Actively Trying Personal Lubricant Unfragrance | CC Wellness, LLC | 2022-02-09 |
| K193450 | Pre-Seed™ Fertility Lubricant | Church & Dwight Co., Inc. | 2020-07-23 |
| K190872 | BioGenesis Fertility Lubricant | Good Clean Love, Inc. | 2019-11-07 |
| K182585 | JO Actively Trying Personal Lubricant | United Consortium | 2019-04-26 |
| K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | Biofilm, Inc. | 2015-01-09 |
| K131355 | CONCEIVE PLUS | Sasmar, Inc. | 2013-11-07 |
| K072741 | PRE-VA VAGINAL LUBRICANT | Ingfertility, LLC | 2008-07-16 |
| K051436 | PRE' VAGINAL LUBRICANT | Ingfertlity, LLC | 2006-10-13 |
Legacy Summary#
summary
FDA Review#
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