Tulux-Filter
FDA 510(k) K892517 · Espe GmbH (Us)
510(k) numberK892517
Submission
- Device name
- Tulux-Filter
- Applicant
- Espe GmbH (Us)
Lake Worth, FL, US - Received
- April 11, 1989
- Decision date
- August 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K904096 | Photac-BondEJK · Traditional | 11/19/1990SE |
| K904097 | Photac-Bond AplicapEJK · Traditional | 11/09/1990SE |
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Questions and answers
When was Tulux-Filter cleared by the FDA?
Tulux-Filter (K892517) received a 510(k) decision of Substantially Equivalent on August 21, 1989, 132 days after the submission was received.
What is the product code of K892517?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.