K910363 is an FDA 510(k) clearance for the MEGA DRESSING CHANGE KIT. This device is classified as a Wound Dressing Kit (Class II - Special Controls, product code MCY).
Submitted by Megadyne Medical Products, Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 28, 1991, 58 days after receiving the submission on January 29, 1991.
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 | K910363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1991 |
| Decision Date | March 28, 1991 |
| Days to Decision | 58 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. |