K935483 is an FDA 510(k) clearance for the E-Z PREP(R) TRAY WITH HIBICLENS(R). This device is classified as a General Surgery Tray (Class II - Special Controls, product code LRO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on February 9, 1994, 86 days after receiving the submission on November 15, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4370. 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 | K935483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1993 |
| Decision Date | February 09, 1994 |
| Days to Decision | 86 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 |