K950295 is an FDA 510(k) clearance for the WOUND CLOSURE/LACERATION TRAY. This device is classified as a General Surgery Tray (Class II - Special Controls, product code LRO).
Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on April 18, 1995, 84 days after receiving the submission on January 24, 1995.
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 | K950295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1995 |
| Decision Date | April 18, 1995 |
| Days to Decision | 84 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 |