The following data is part of a premarket notification filed by Weinmann Gerate Fur Medizin Gmbh + Co. Kg with the FDA for Soyala Silkgel Full Face Mask.
| Device ID | K112167 |
| 510k Number | K112167 |
| Device Name: | SOYALA SILKGEL FULL FACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG KRONSAALSWEG 40 Hamburg, DE 22525 |
| Contact | Ralf Egenolf |
| Correspondent | Ralf Egenolf WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG KRONSAALSWEG 40 Hamburg, DE 22525 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-28 |
| Decision Date | 2011-11-16 |
| Summary: | summary |