The following data is part of a premarket notification filed by Plastimed Laboratoire Pharmaceutique with the FDA for Combicath Catheter.
| Device ID | K974642 |
| 510k Number | K974642 |
| Device Name: | COMBICATH CATHETER |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PLASTIMED LABORATOIRE PHARMACEUTIQUE 212 3RD AVENUE NORTH SUITE #446 Minneapolis, MN 55401 |
| Contact | Mike Mccormick |
| Correspondent | Mike Mccormick PLASTIMED LABORATOIRE PHARMACEUTIQUE 212 3RD AVENUE NORTH SUITE #446 Minneapolis, MN 55401 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-15 |
| Decision Date | 1998-03-13 |
| Summary: | summary |