Container, Embedding
FDA product code KER · Class I (low risk) · 21 CFR 864.3010 · Pathology
5510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831922 | Embedding RingKER · Traditional | Polymer Technology Corp. | 07/29/1983SE |
| K831900 | Maclean-Fogg, Disp. Base MoldKER · Traditional | Polymer Technology Corp. | 07/28/1983SE |
| K831333 | Embedding RingsKER · Traditional | Surgipath Medical Industries, Inc. | 05/25/1983SE |
| K831335 | Disposable Base MoldKER · Traditional | Surgipath Medical Industries, Inc. | 05/16/1983SE |
| K772149 | Lancer Biopsy HolderKER · Traditional | Sherwood Medical Industries | 11/22/1977SE |