The following data is part of a premarket notification filed by Fairhaven Health, Llc with the FDA for Sage 2-in-1 Personal Lubricant And Moisturizer.
| Device ID | K190150 |
| 510k Number | K190150 |
| Device Name: | Sage 2-in-1 Personal Lubricant And Moisturizer |
| Classification | Lubricant, Personal |
| 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 | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-30 |
| Decision Date | 2019-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00896593002503 | K190150 | 000 |