Submission Details
| 510(k) Number | K162030 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 2016 |
| Decision Date | August 19, 2016 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
Aug 2016
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K162030 is an FDA 510(k) clearance for the 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle, 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 August 19, 2016, 28 days after receiving the submission on July 22, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | MEG — Syringe, Antistick |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Manufacturer
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