The following data is part of a premarket notification filed by Medefil, Inc. with the FDA for Medefil's Normal Saline I.v. Flush Syringe.
| Device ID | K091583 |
| 510k Number | K091583 |
| Device Name: | MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE |
| Classification | Saline, Vascular Access Flush |
| Applicant | MEDEFIL, INC. 250 WINDY POINT DR. Glendale Heights, IL 60139 |
| Contact | Pradeep Aggarwal |
| Correspondent | Pradeep Aggarwal MEDEFIL, INC. 250 WINDY POINT DR. Glendale Heights, IL 60139 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-02 |
| Decision Date | 2010-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50364253111520 | K091583 | 000 |
| 30364253111359 | K091583 | 000 |
| 30364253111335 | K091583 | 000 |
| 30364253111304 | K091583 | 000 |
| 30364253111250 | K091583 | 000 |
| 30364253111236 | K091583 | 000 |
| 50364253111223 | K091583 | 000 |
| 50364253111216 | K091583 | 000 |