This page includes the latest FDA filings for Fractyl Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3012744132 |
| FEI Number | 3012744132 |
| Name | FRACTYL LABORATORIES, INC. |
| Owner & Operator | Fractyl Laboratories, Inc. |
| Contact Address | 17 Hartwell Avenue Lexington MA 02421 US |
| Official Correspondent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 17 Hartwell Avenue Lexington, MA 02421 US |
| Establishment Type | Manufacture Device in the United States for Export Only |
Device Company | Device | Date |
|---|---|---|
FRACTYL LABORATORIES, INC. | Revita System | 2018-05-07 |
| NCAGE Code | 5C682 | FRACTYL LABORATORIES INC.!DBA FRACTYL LABS |
| CAGE Code | 5C682 | FRACTYL LABORATORIES INC. FRACTYL LABS |
| S.A.M. Registration | 5C682 [10088244] | FRACTYL LABORATORIES INC. FRACTYL LABS |
| SEC | 0001572616 | Fractyl Laboratories Inc. of DELAWARE |