← Product Code [LRQ](/productcode/LRQ) · K963720

# TRACHEOSTOMY KIT (K963720)

_Grand Medical Products · LRQ · Nov 27, 1996 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K963720

## Device Facts

- **Applicant:** Grand Medical Products
- **Product Code:** [LRQ](/productcode/LRQ.md)
- **Decision Date:** Nov 27, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class 1
- **Review Panel:** SU

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/device/K963720](https://fda.innolitics.com/device/K963720)

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