KER — Container, Embedding Class I
FDA product code KER covers "Container, Embedding", a Class I medical device regulated under 21 CFR 864.3010. Submissions are reviewed by the Pathology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KER
- Device Class
- Class I
- Regulation Number
- 864.3010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K831922 | polymer technology | EMBEDDING RING | July 29, 1983 |
| K831900 | polymer technology | MACLEAN-FOGG, DISP. BASE MOLD | July 28, 1983 |
| K831333 | surgipath medical industries | EMBEDDING RINGS | May 25, 1983 |
| K831335 | surgipath medical industries | DISPOSABLE BASE MOLD | May 16, 1983 |
| K772149 | sherwood medical industries | LANCER BIOPSY HOLDER | November 22, 1977 |