Busse Plastic Lor Syringe
FDA 510(k) K080804 · Busse Hosipital Disposables
510(k) numberK080804
Submission
- Device name
- Busse Plastic Lor Syringe
- Applicant
- Busse Hosipital Disposables
Hauppauge, NY, US - Received
- March 21, 2008
- Decision date
- July 9, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
Other 510(k)s with product code CAZ
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|---|---|---|---|
| K222341 | Arrow 0.2 Micron Flat Filter, GVSCAZ · Traditional | Arrow International, LLC | 02/13/2023SE |
| K210983 | BD Epilor SyringeCAZ · Traditional | Becton, Dickinson and Company | 05/19/2022SE |
| K201356 | Plastic LOR SyringeCAZ · Traditional | Jiangsu Caina Medical Co.,Ltd | 02/12/2021SE |
| K202699 | E-Cath STIM acc. TsuiCAZ · Special | PAJUNK GmbH Medizintechnologie | 12/29/2020SE |
| K190345 | VPCCAZ · Traditional | PAJUNK GmbH Medizintechnologie | 05/16/2019SE |
| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 10/04/2016SE |
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetCAZ · Traditional | Teleflex, Inc. | 06/21/2016SE |
| K143581 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 06/26/2015SE |
| K122690 | Ultraquik Peripheral Nerve Block NeedleCAZ · Traditional | Arrow International, Inc. | 12/21/2012SE |
| K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitCAZ · Traditional | Smiths Medical Asd, Inc. | 09/14/2012SE |
More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K083424 | Busse Surgical DrapeKKX · Traditional | 02/26/2009SE |
Questions and answers
When was Busse Plastic Lor Syringe cleared by the FDA?
Busse Plastic Lor Syringe (K080804) received a 510(k) decision of Substantially Equivalent on July 9, 2008, 110 days after the submission was received.
What is the product code of K080804?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.