The following data is part of a premarket notification filed by Primed Halberstadt Medizintechnik Gmbh with the FDA for Primed Tracheostomy Tubes (multiple).
| Device ID | K120079 |
| 510k Number | K120079 |
| Device Name: | PRIMED TRACHEOSTOMY TUBES (MULTIPLE) |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | PRIMED HALBERSTADT MEDIZINTECHNIK GMBH STRASSE DES 20. JULI NR.1 Halberstadt, DE 38820 |
| Contact | Alexandra Singer |
| Correspondent | Alexandra Singer PRIMED HALBERSTADT MEDIZINTECHNIK GMBH STRASSE DES 20. JULI NR.1 Halberstadt, DE 38820 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-10 |
| Decision Date | 2012-05-24 |
| Summary: | summary |