LRQ · Tracheostomy And Nasal Suctioning Kit
· Class 1
Overview
| Product Code | LRQ |
|---|---|
| Device Name | Tracheostomy And Nasal Suctioning Kit |
| Device Class | Class 1 |
| Review Panel |
Identification
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 Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963720 | TRACHEOSTOMY KIT | Grand Medical Products | Nov 27, 1996 | SESE |
| K961167 | MEDCARE TRACHEOSTOMY CARE TRAY | Medcare Medical Group, Inc. | Jul 2, 1996 | SESK |
| K952925 | READY NURSE SYSTEM (RNS) TRACH CARE KIT | Contour Fabricators of Florida, Inc. | Jul 12, 1995 | SESK |
| K950851 | GENT-L-KARE TRACHEOSTOMY TRAYS | Premium Plastics, Inc. | Jun 21, 1995 | SESE |
| K871692 | TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 | Automatic Liquid Packaging, Inc. | Jun 1, 1987 | SESE |
| K862663 | TRACHEOSTOMY CARE TRAY | Welmed Systems, Inc. | Jul 30, 1986 | SESE |
Top Applicants
- Automatic Liquid Packaging, Inc. — 1 clearance
- Contour Fabricators of Florida, Inc. — 1 clearance
- Grand Medical Products — 1 clearance
- Medcare Medical Group, Inc. — 1 clearance
- Premium Plastics, Inc. — 1 clearance
