K964827 is an FDA 510(k) clearance for the PROD. NO. 01-132 - SUTURE REMOVAL KIT, a Suture Removal Kit (Class I — General Controls, product code MCZ), submitted by Continental Medical Laboratories, Inc. (Waterford, US). The FDA issued a Cleared decision on February 14, 1997, 74 days after receiving the submission on December 2, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K964827 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 1996 |
| Decision Date | February 14, 1997 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| 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. |