K050575 is an FDA 510(k) clearance for the FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM. This device is classified as a Instrument, Manual, Surgical, General Use (Class I - General Controls, product code MDM).
Submitted by Futumeds Sdn Bhd (Puchong, MY). The FDA issued a Cleared decision on August 15, 2005, 161 days after receiving the submission on March 7, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K050575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2005 |
| Decision Date | August 15, 2005 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MDM — Instrument, Manual, Surgical, General Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |