The following data is part of a premarket notification filed by Medefil, Inc. with the FDA for Medefil's Heparin I.v. Flush Syringe In Various Fill Sizes - 1 Ml Fill In 6 Ml Syringe Ll; 2 Ml Fill In 6 Ml Syringe Ll.
| Device ID | K020996 |
| 510k Number | K020996 |
| Device Name: | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL |
| Classification | Saline, Vascular Access Flush |
| Applicant | MEDEFIL, INC. 492 LUNT AVE. Schaumburg, IL 60193 |
| Contact | Pradeep Aggarwal |
| Correspondent | Pradeep Aggarwal MEDEFIL, INC. 492 LUNT AVE. Schaumburg, IL 60193 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2002-03-28 |
| Decision Date | 2002-06-24 |
| Summary: | summary |