LRQ — Tracheostomy And Nasal Suctioning Kit Class I
Classification Details
- Product Code
- LRQ
- Device Class
- Class I
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K963720 | grand medical products | TRACHEOSTOMY KIT | November 27, 1996 |
| K961167 | medcare medical group | MEDCARE TRACHEOSTOMY CARE TRAY | July 2, 1996 |
| K952925 | contour fabricators of florida | READY NURSE SYSTEM (RNS) TRACH CARE KIT | July 12, 1995 |
| K950851 | premium plastics | GENT-L-KARE TRACHEOSTOMY TRAYS | June 21, 1995 |
| K871692 | automatic liquid packaging | TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 | June 1, 1987 |
| K862663 | welmed systems | TRACHEOSTOMY CARE TRAY | July 30, 1986 |