Maclean-Fogg, Disp. Base Mold
FDA 510(k) K831900 · Polymer Technology Corp.
510(k) numberK831900
Submission
- Device name
- Maclean-Fogg, Disp. Base Mold
- Applicant
- Polymer Technology Corp.
Mchenry, IL, US - Received
- June 14, 1983
- Decision date
- July 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KER
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831922 | Embedding RingKER · Traditional | Polymer Technology Corp. | 07/29/1983SE |
| 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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| K003932 | Boston Eo (Enflufocon B) Contact Lens for OrthokeratolgyHQD · Traditional | 02/16/2001SE |
| 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 Maclean-Fogg, Disp. Base Mold cleared by the FDA?
Maclean-Fogg, Disp. Base Mold (K831900) received a 510(k) decision of Substantially Equivalent on July 28, 1983, 44 days after the submission was received.
What is the product code of K831900?
The FDA product code is KER – Container, Embedding, a Class I (low risk) device regulated under 21 CFR 864.3010.