The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Rusch Safety Silk Pediatric Series Oral/nasal Tracheal Tube.
| Device ID | K150603 |
| 510k Number | K150603 |
| Device Name: | Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-10 |
| Decision Date | 2015-11-27 |