K862663 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE TRAY. This device is classified as a Tracheostomy And Nasal Suctioning Kit (Class I - General Controls, product code LRQ).
Submitted by Welmed Systems, Inc. (West Swanzey, US). The FDA issued a Cleared decision on July 30, 1986, 16 days after receiving the submission on July 14, 1986.
This device falls under the General & Plastic Surgery FDA review panel. 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..
| 510(k) Number | K862663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1986 |
| Decision Date | July 30, 1986 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| 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. |