K951476 is an FDA 510(k) clearance for the E-PACK PROCEDURE KITS. This device is classified as a Wound Dressing Kit (Class II - Special Controls, product code MCY).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 23, 1995, 54 days after receiving the submission on March 30, 1995.
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 | K951476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | March 30, 1995 |
| Decision Date | May 23, 1995 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |