The following data is part of a premarket notification filed by Shin Chang Medical Co., Ltd. with the FDA for Profi Disposable Syringe, Profi Disposable Needle, Dm Ject Insulin Syringe.
| Device ID | K993017 |
| 510k Number | K993017 |
| Device Name: | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | SHIN CHANG MEDICAL CO., LTD. 3762 SOUTH 150 EAST Salt Lake City, UT 84115 |
| Contact | Jan J Frank |
| Correspondent | Jan J Frank SHIN CHANG MEDICAL CO., LTD. 3762 SOUTH 150 EAST Salt Lake City, UT 84115 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-08 |
| Decision Date | 2000-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00021292005887 | K993017 | 000 |
| 50096295125394 | K993017 | 000 |
| 18800109000012 | K993017 | 000 |
| 18800109000418 | K993017 | 000 |
| 18800109000616 | K993017 | 000 |
| 18800109001576 | K993017 | 000 |
| 18800109001583 | K993017 | 000 |
| 18800109001590 | K993017 | 000 |
| 18800109050017 | K993017 | 000 |
| 18800109050413 | K993017 | 000 |
| 18800109050611 | K993017 | 000 |
| 00021292005863 | K993017 | 000 |
| 00021292005870 | K993017 | 000 |
| 00021292005849 | K993017 | 000 |