Submission Details
| 510(k) Number | K132681 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
May 2014
Decision
267d
Days
Class 2
Risk
About This 510(k) Submission
K132681 is an FDA 510(k) clearance for the SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE, 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 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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