K050656 is an FDA 510(k) clearance for the AMSINO SUTURE REMOVAL KIT. This device is classified as a Suture Removal Kit (Class I - General Controls, product code MCZ).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on May 2, 2005, 49 days after receiving the submission on March 14, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. 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 | K050656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2005 |
| Decision Date | May 02, 2005 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MCZ — Suture Removal Kit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. 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. |