The following data is part of a premarket notification filed by Poonglim Pharmatech Inc. with the FDA for Kopac Sterile Needle.
| Device ID | K172483 |
| 510k Number | K172483 |
| Device Name: | Kopac Sterile Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Poonglim Pharmatech Inc. 21, Jayumuyeok 1-gil Gunsan-si, KR 54001 |
| Contact | Cho Hee Min |
| Correspondent | Peter Chung Plus Global 300 Atwood Pittsburgh, PA 15213 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-16 |
| Decision Date | 2018-06-21 |
| Summary: | summary |