K963719 is an FDA 510(k) clearance for the CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY, a Wound Dressing Kit (Class II — Special Controls, product code MCY), submitted by Grand Medical Products (Schaumburg, US). The FDA issued a Cleared decision on November 27, 1996, 72 days after receiving the submission on September 16, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5075.
| 510(k) Number | K963719 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 1996 |
| Decision Date | November 27, 1996 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MCY — Wound Dressing Kit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5075 |
| 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. |