The following data is part of a premarket notification filed by Cs Medical Inc. with the FDA for Cs Medical Adult Ttcf Catheter.
| Device ID | K050379 |
| 510k Number | K050379 |
| Device Name: | CS MEDICAL ADULT TTCF CATHETER |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | CS MEDICAL INC. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward CS MEDICAL INC. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-15 |
| Decision Date | 2005-07-12 |
| Summary: | summary |