36-101 XDS111 Xenon Delivery/Trap System
FDA 510(k) K860504 · Victoreen, Inc.
510(k) numberK860504
Submission
- Device name
- 36-101 XDS111 Xenon Delivery/Trap System
- Applicant
- Victoreen, Inc.
Carle Place, NY, US - Received
- February 11, 1986
- Decision date
- April 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was 36-101 XDS111 Xenon Delivery/Trap System cleared by the FDA?
36-101 XDS111 Xenon Delivery/Trap System (K860504) received a 510(k) decision of Substantially Equivalent on April 4, 1986, 52 days after the submission was received.
What is the product code of K860504?
The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.