The following data is part of a premarket notification filed by Unoplast A/s with the FDA for Suction Catheter Straight/coude.
| Device ID | K896730 |
| 510k Number | K896730 |
| Device Name: | SUCTION CATHETER STRAIGHT/COUDE |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | UNOPLAST A/S DK-3390 HUNDESTED Denmark, DK |
| Contact | Erik Andersen |
| Correspondent | Erik Andersen UNOPLAST A/S DK-3390 HUNDESTED Denmark, DK |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-30 |
| Decision Date | 1990-03-30 |