K041080 is an FDA 510(k) clearance for the SURGICAL DRAPE KIT - D.I.R.R.A. SRL, a General Surgery Tray (Class II — Special Controls, product code LRO), submitted by D.I.R.R.A. S.R.L. (Viadana, Mantova, IT). The FDA issued a Cleared decision on November 30, 2004, 218 days after receiving the submission on April 26, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K041080 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 26, 2004 |
| Decision Date | November 30, 2004 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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 |