K964921 is an FDA 510(k) clearance for the BASIC BIOPSY TRAY. DISPOSABLE, STERILE, a General Surgery Tray (Class II — Special Controls, product code LRO), submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on January 22, 1997, 44 days after receiving the submission on December 9, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K964921 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 09, 1996 |
| Decision Date | January 22, 1997 |
| Days to Decision | 44 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 |