The following data is part of a premarket notification filed by Intersect Medical Products, Inc. with the FDA for Gamgro Engstrom Y Filter With Edith Flex (1500 F), Edit 500, 1000, 2600 And Y Filter Packaged Alone.
| Device ID | K945543 |
| 510k Number | K945543 |
| Device Name: | GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | INTERSECT MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, MN 55424 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman INTERSECT MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, MN 55424 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1994-11-29 |