K962826 is an FDA 510(k) clearance for the MEDLINE RADIOLOGY-DIAGNOSTIC KITS. This device is classified as a General Surgery Tray (Class II - Special Controls, product code LRO).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on September 16, 1996, 59 days after receiving the submission on July 19, 1996.
This device falls under the Radiology 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 | K962826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1996 |
| Decision Date | September 16, 1996 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| 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 |