Probloc Insulated Needles
FDA 510(k) K926349 · Life-Tech Intl., Inc.
510(k) numberK926349
Submission
- Device name
- Probloc Insulated Needles
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- December 17, 1992
- Decision date
- July 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Probloc Insulated Needles cleared by the FDA?
Probloc Insulated Needles (K926349) received a 510(k) decision of Substantially Equivalent on July 29, 1993, 224 days after the submission was received.
What is the product code of K926349?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.