The following data is part of a premarket notification filed by International Medsurg Connection with the FDA for Piston Syringe & Hypodermic Needle.
| Device ID | K022159 |
| 510k Number | K022159 |
| Device Name: | PISTON SYRINGE & HYPODERMIC NEEDLE |
| Classification | Syringe, Piston |
| Applicant | INTERNATIONAL MEDSURG CONNECTION P.O. BOX 848 Grayslake, IL 60030 |
| Contact | Michele H Vovolka |
| Correspondent | Michele H Vovolka INTERNATIONAL MEDSURG CONNECTION P.O. BOX 848 Grayslake, IL 60030 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2002-11-07 |
| Summary: | summary |