The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Fiberflo Hollow Fiber Cartridge Water Filters.
| Device ID | K954349 |
| 510k Number | K954349 |
| Device Name: | FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS |
| Classification | Subsystem, Water Purification |
| Applicant | MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Contact | Leroy J Fischbach |
| Correspondent | Leroy J Fischbach MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1995-12-15 |