Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382
FDA 510(k) K052111 · Excel Tech. , Ltd.
510(k) numberK052111
Submission
- Device name
- Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382
- Applicant
- Excel Tech. , Ltd.
Oakville, CA - Received
- August 4, 2005
- Decision date
- August 17, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382 cleared by the FDA?
Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382 (K052111) received a 510(k) decision of Substantially Equivalent on August 17, 2005, 13 days after the submission was received.
What is the product code of K052111?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.