The following data is part of a premarket notification filed by Medefil, Inc. with the FDA for Medeflush Normal Saline I.v. Flush Syringe-sterile Field Ready.
| Device ID | K121262 |
| 510k Number | K121262 |
| Device Name: | MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY |
| 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 | 2012-04-26 |
| Decision Date | 2012-09-20 |
| Summary: | summary |