K132681 is an FDA 510(k) clearance for the SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Sol-Millennium Medical, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on May 22, 2014, 267 days after receiving the submission on August 28, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K132681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2013 |
| Decision Date | May 22, 2014 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |