TRACHEOSTOMY KIT
Device Facts
| Record ID | K963720 |
|---|---|
| Device Name | TRACHEOSTOMY KIT |
| Applicant | Grand Medical Products |
| Product Code | LRQ · SU |
| Decision Date | Nov 27, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class 1 |
Regulatory Classification
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.
