K905123 is an FDA 510(k) clearance for the G-TUBE DRESSING CHANGE TRAY. This device is classified as a Wound Dressing Kit (Class II - Special Controls, product code MCY).
Submitted by Continental Medical Laboratories, Inc. (Waterford, US). The FDA issued a Cleared decision on March 27, 1991, 133 days after receiving the submission on November 14, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5075. 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 | K905123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1990 |
| Decision Date | March 27, 1991 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| 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. |