FDA Product Code
FDA Product Code MSC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5300
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253662 | LIXI (LXOSFM1) | Luwi, LLC | 2026-07-14 | Traditional | PDF ↗ |
| K212928 | Lorals | Brazen Goods Inc. Dba Lorals | 2022-04-22 | Traditional | PDF ↗ |
| K212037 | SancDam Latex Oral Dam | Sanctuary Health Sdn. Bhd. | 2022-03-28 | Traditional | PDF ↗ |
| K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Pamco Distributing, Inc. | 2021-08-05 | Traditional | PDF ↗ |
| K091769 | TRUST DAM | Line One Laboratories, Inc. | 2010-02-05 | Abbreviated | PDF ↗ |
| K990067 | SHEER GLYDE DAMS | Louise C. Myers | 1999-02-19 | Traditional | PDF ↗ |
| K970577 | GLYDE DAM LOLLYES | Glyde USA, Inc. | 1998-01-08 | Traditional | PDF ↗ |
Product code MSC · Class II · Obstetrics/Gynecology. Data: openFDA.