Embedding Ring
FDA 510(k) K831922 · Polymer Technology Corp.
510(k) numberK831922
Submission
- Device name
- Embedding Ring
- Applicant
- Polymer Technology Corp.
Mchenry, IL, US - Received
- June 14, 1983
- Decision date
- July 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KER
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
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| K002025 | Rigid Gas Permeable Contact LensHQD · Traditional | 10/31/2000SE |
| K001960 | Rigid Gas Permeable Contact LensHQD · Traditional | 08/28/2000SE |
| K000795 | Rigid Gas Permeable Contact LensHQD · Traditional | 05/26/2000SE |
| K980133 | Bausch & Lomb Wetting and Soaking SolutionLPN · Traditional | 03/11/1998SE |
| K974466 | Boston Advance CleanerMRC · Traditional | 02/19/1998SE |
| K973217 | Boston Liquid Enzymatic CleanerLPN · Traditional | 11/24/1997SE |
| K970698 | Boston Es Multivision (Enflufocon a) Contact LensHQD · Traditional | 05/06/1997SE |
Questions and answers
When was Embedding Ring cleared by the FDA?
Embedding Ring (K831922) received a 510(k) decision of Substantially Equivalent on July 29, 1983, 45 days after the submission was received.
What is the product code of K831922?
The FDA product code is KER – Container, Embedding, a Class I (low risk) device regulated under 21 CFR 864.3010.