The following data is part of a premarket notification filed by Medefil, Inc. with the FDA for Medefil's Heparin I.v. Flush Syringe 1 Unit/ml; 10 Units/ml; And 100 Units/ml In Various Fill Sizes.
| Device ID | K092491 |
| 510k Number | K092491 |
| Device Name: | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES |
| Classification | Heparin, 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 | NZW |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-08-13 |
| Decision Date | 2010-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50364253444529 | K092491 | 000 |
| 30364253333232 | K092491 | 000 |
| 50364253333229 | K092491 | 000 |
| 30364253333218 | K092491 | 000 |
| 70364253222350 | K092491 | 000 |
| 30364253222338 | K092491 | 000 |
| 50364253222301 | K092491 | 000 |
| 50364253222257 | K092491 | 000 |
| 30364253222239 | K092491 | 000 |
| 50364253222226 | K092491 | 000 |
| 50364253333250 | K092491 | 000 |
| 50364253333304 | K092491 | 000 |
| 50364253444352 | K092491 | 000 |
| 50364253444338 | K092491 | 000 |
| 50364253444307 | K092491 | 000 |
| 30364253444259 | K092491 | 000 |
| 50364253444239 | K092491 | 000 |
| 30364253444228 | K092491 | 000 |
| 50364253444215 | K092491 | 000 |
| 50364253333526 | K092491 | 000 |
| 30364253333331 | K092491 | 000 |
| 30364253222215 | K092491 | 000 |