Submission Details
| 510(k) Number | K172483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 2017 |
| Decision Date | June 21, 2018 |
| Days to Decision | 309 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Kopac Sterile Needle
Jun 2018
Decision
309d
Days
Class 2
Risk
About This 510(k) Submission
K172483 is an FDA 510(k) clearance for the Kopac Sterile Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Poonglim Pharmatech, Inc. (Gunsan, KR). The FDA issued a Cleared decision on June 21, 2018, 309 days after receiving the submission on August 16, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
Manufacturer
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