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 3 Ml Syringe Ll; 1 Ml Fill In 6 Ml Syringe Ll.
| Device ID | K993518 |
| 510k Number | K993518 |
| Device Name: | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-18 |
| Decision Date | 2000-06-12 |