The following data is part of a premarket notification filed by Ni-med, Inc. with the FDA for Suction Catheter.
| Device ID | K981910 |
| 510k Number | K981910 |
| Device Name: | SUCTION CATHETER |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | NI-MED, INC. 1601 AIR PARK DR. P.O. BOX 871 Farmington, MO 63640 |
| Contact | Michael Giblin |
| Correspondent | Michael Giblin NI-MED, INC. 1601 AIR PARK DR. P.O. BOX 871 Farmington, MO 63640 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-01 |
| Decision Date | 1998-08-24 |