510(k) K993017

PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE by Shinchang Medical Co., Ltd. — Product Code FMF

K993017 is an FDA 510(k) premarket notification submitted by Shinchang Medical Co., Ltd. for the device "PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE". The FDA issued a decision of Substantially Equivalent on February 25, 2000. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Shinchang Medical Co., Ltd. has at least 2 other 510(k) clearances on record.