K935858 is an FDA 510(k) clearance for the MILL-ROSE PERCUTANEOUS PROCEDURAL KIT, a General Surgery Tray (Class II — Special Controls, product code LRO), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on February 22, 1994, 76 days after receiving the submission on December 8, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K935858 FDA.gov |
| FDA Decision | Cleared SEKD |
| Date Received | December 08, 1993 |
| Decision Date | February 22, 1994 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | LRO — General Surgery Tray |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4370 |
| 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 |