Submission Details
| 510(k) Number | K122373 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 06, 2012 |
| Decision Date | September 20, 2012 |
| Days to Decision | 45 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
NEOMED ORAL/ENTERAL SYRINGE
Sep 2012
Decision
45d
Days
Class 2
Risk
About This 510(k) Submission
K122373 is an FDA 510(k) clearance for the NEOMED ORAL/ENTERAL SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Neomed, Inc. (Woodstock, US). The FDA issued a Cleared decision on September 20, 2012, 45 days after receiving the submission on August 6, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Manufacturer
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