The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Fiberflo Hollow Fiber Capsule Water Filters.
| Device ID | K983126 |
| 510k Number | K983126 |
| Device Name: | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS |
| Classification | Subsystem, Water Purification |
| Applicant | MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Contact | Mark Murphy |
| Correspondent | Mark Murphy 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 | 1998-09-08 |
| Decision Date | 1999-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00677964053566 | K983126 | 000 |
| 00677964032134 | K983126 | 000 |
| 00677964032127 | K983126 | 000 |
| 30677964032081 | K983126 | 000 |
| 00677964031823 | K983126 | 000 |
| 00677964031502 | K983126 | 000 |
| 00677964031472 | K983126 | 000 |
| 00677964031458 | K983126 | 000 |
| 00677964031441 | K983126 | 000 |
| 00677964031434 | K983126 | 000 |
| 00677964031410 | K983126 | 000 |
| 00677964031403 | K983126 | 000 |
| 00677964031397 | K983126 | 000 |
| 00677964031250 | K983126 | 000 |
| 00677964031243 | K983126 | 000 |
| 00677964031236 | K983126 | 000 |
| 00677964031212 | K983126 | 000 |
| 00677964031205 | K983126 | 000 |
| 00677964032141 | K983126 | 000 |
| 00677964032295 | K983126 | 000 |
| 00677964032301 | K983126 | 000 |
| 00677964052514 | K983126 | 000 |
| 00677964044236 | K983126 | 000 |
| 00677964042560 | K983126 | 000 |
| 00677964042553 | K983126 | 000 |
| 00677964042546 | K983126 | 000 |
| 00677964042478 | K983126 | 000 |
| 00677964042454 | K983126 | 000 |
| 00677964042423 | K983126 | 000 |
| 00677964042416 | K983126 | 000 |
| 00677964042393 | K983126 | 000 |
| 00677964032721 | K983126 | 000 |
| 00677964032653 | K983126 | 000 |
| 00677964032639 | K983126 | 000 |
| 00677964032585 | K983126 | 000 |
| 00677964032578 | K983126 | 000 |
| 00677964032424 | K983126 | 000 |
| 00677964032363 | K983126 | 000 |
| 00677964031199 | K983126 | 000 |