The following data is part of a premarket notification filed by Dhd Diemolding Healthcare Div. with the FDA for Ultraset Catheter.
| Device ID | K911294 |
| 510k Number | K911294 |
| Device Name: | ULTRASET CATHETER |
| Classification | Connector, Airway (extension) |
| Applicant | DHD DIEMOLDING HEALTHCARE DIV. 125 RASBACH ST. Canastota, NY 13032 |
| Contact | Jean Wallace |
| Correspondent | Jean Wallace DHD DIEMOLDING HEALTHCARE DIV. 125 RASBACH ST. Canastota, NY 13032 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-25 |
| Decision Date | 1991-06-10 |