K951478 is an FDA 510(k) clearance for the GENERAL AND PLASTIC SURGERY PACKS. This device is classified as a General Surgery Tray (Class II - Special Controls, product code LRO).
Submitted by Sterile Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on June 13, 1995, 75 days after receiving the submission on March 30, 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 | K951478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1995 |
| Decision Date | June 13, 1995 |
| Days to Decision | 75 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 |