The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type 9291 Interface Respirator.
| Device ID | K896736 |
| 510k Number | K896736 |
| Device Name: | TYPE 9291 INTERFACE RESPIRATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Lisbeth Isbrandt |
| Correspondent | Lisbeth Isbrandt S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-30 |
| Decision Date | 1990-02-28 |