MSC — Barrier, Std, Oral Sex Class II
FDA product code MSC covers "Barrier, Std, Oral Sex", a Class II medical device regulated under 21 CFR 884.5300. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MSC
- Device Class
- Class II
- Regulation Number
- 884.5300
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K212928 | brazen goods inc. dba lorals | Lorals | April 22, 2022 |
| K212037 | sanctuary health sdn. bhd | SancDam Latex Oral Dam | March 28, 2022 |
| K203727 | pamco distributing | Harmony Latex Dam, Harmony Non-Latex Dam | August 5, 2021 |
| K091769 | line one laboratories | TRUST DAM | February 5, 2010 |
| K990067 | louise c. myers | SHEER GLYDE DAMS | February 19, 1999 |
| K970577 | glyde usa | GLYDE DAM LOLLYES | January 8, 1998 |