K950851 is an FDA 510(k) clearance for the GENT-L-KARE TRACHEOSTOMY TRAYS, a Tracheostomy And Nasal Suctioning Kit (Class I — General Controls, product code LRQ), submitted by Premium Plastics, Inc. (Chicago, US). The FDA issued a Cleared decision on June 21, 1995, 117 days after receiving the submission on February 24, 1995. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K950851 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 1995 |
| Decision Date | June 21, 1995 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LRQ — Tracheostomy And Nasal Suctioning Kit |
| Device Class | Class I — General Controls |
| 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. |