K940518 is an FDA 510(k) clearance for the C-SECTION TRAY, a Labor And Delivery Kit (Class II — Special Controls, product code MLS), submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on August 18, 1994, 195 days after receiving the submission on February 4, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K940518 FDA.gov |
| FDA Decision | Cleared SEKD |
| Date Received | February 04, 1994 |
| Decision Date | August 18, 1994 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MLS — Labor And Delivery Kit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| 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 |