Plastic LOR Syringe
FDA 510(k) K201356 · Jiangsu Caina Medical Co.,Ltd
510(k) numberK201356
Submission
- Device name
- Plastic LOR Syringe
- Applicant
- Jiangsu Caina Medical Co.,Ltd
Jiangyin, CN - Received
- May 21, 2020
- Decision date
- February 12, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAZ – Anesthesia Conduction Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5140
- Specialty
- Anesthesiology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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Questions and answers
When was Plastic LOR Syringe cleared by the FDA?
Plastic LOR Syringe (K201356) received a 510(k) decision of Substantially Equivalent on February 12, 2021, 267 days after the submission was received.
What is the product code of K201356?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.