The following data is part of a premarket notification filed by Spiritus Technologies Llc with the FDA for Spirtius Cuff Inflation Syringe.
| Device ID | K112915 |
| 510k Number | K112915 |
| Device Name: | SPIRTIUS CUFF INFLATION SYRINGE |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | SPIRITUS TECHNOLOGIES LLC 12005 W. 100TH TERRACE Lenexa, KS 66215 |
| Contact | Brandon W Close |
| Correspondent | Brandon W Close SPIRITUS TECHNOLOGIES LLC 12005 W. 100TH TERRACE Lenexa, KS 66215 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2012-05-25 |
| Summary: | summary |