Redi Nurse System (RNS) Pre-Filled 10CC, 30CC, 60CC Syringe W/Sterile Water
FDA 510(k) K952407 · Contour Fabricators of Florida, Inc.
510(k) numberK952407
Submission
- Device name
- Redi Nurse System (RNS) Pre-Filled 10CC, 30CC, 60CC Syringe W/Sterile Water
- Applicant
- Contour Fabricators of Florida, Inc.
St. Petersburg, FL, US - Received
- May 22, 1995
- Decision date
- August 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KYZ – Syringe, Irrigating (Non Dental)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6960
- Specialty
- General Hospital
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| K991254 | QS Delivery SystemKYZ · Traditional | Sub-Q, Inc. | 08/23/1999SE |
| K982435 | Irrigation Syringe KitKYZ · Traditional | Sub-Q, Inc. | 11/06/1998SE |
| K974288 | Zerowet SplashieldKYZ · Traditional | Zerowet, Inc. | 01/29/1998SE |
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | Research Medical, Inc. | 02/19/1997SE |
| K960725 | Marpp Pressure Monitoring SystemKYZ · Traditional | Paradigm Medical, Inc. | 07/15/1996SE |
| K960212 | CPR Irrigation TrayKYZ · Traditional | Custom Pack Reliability | 04/01/1996SE |
More from Custom Pack Reliability
| 510(k) | Device | Decision |
|---|---|---|
| K955685 | RNS Sterile, Disposable CT Biopsy TrayDXT · Traditional | 10/04/1996SE |
| K962040 | RNS Arthrogram TrayFMI · Traditional | 06/25/1996SE |
| K955687 | RNS Sterile, Disposable Radiographic Contrast TrayJAA · Traditional | 06/03/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | 05/15/1996SE |
| K955684 | RNS Sterile, Disposable Angiographic TrayDXT · Traditional | 05/02/1996SESK |
| K955679 | RNS Sterile, Disposable Amniocentesis TrayHIO · Traditional | 03/12/1996SE |
| K955688 | RNS Sterile, Disposable Standard Biopsy TrayFRG · Traditional | 02/21/1996SE |
| K955686 | RNS, Sterile Disposable Percutaneous Cholangiographic TrayFRG · Traditional | 02/21/1996SE |
| K955678 | RNS Sterile Disposable Puncture TrayFRG · Traditional | 02/21/1996SE |
| K955683 | RNS Sterile, Disposable Breast Biopsy/Localization TrayMJG · Traditional | 02/01/1996SE |
Questions and answers
When was Redi Nurse System (RNS) Pre-Filled 10CC, 30CC, 60CC Syringe W/Sterile Water cleared by the FDA?
Redi Nurse System (RNS) Pre-Filled 10CC, 30CC, 60CC Syringe W/Sterile Water (K952407) received a 510(k) decision of Substantially Equivalent on August 7, 1995, 77 days after the submission was received.
What is the product code of K952407?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.