The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Rusch Safety Silk Series Oral/nasal Tracheal Tube.
| Device ID | K132415 |
| 510k Number | K132415 |
| Device Name: | RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl Teleflex Medical, Inc. 2917 WECK DR. 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 | 2013-08-02 |
| Decision Date | 2014-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704196689 | K132415 | 000 |
| 24026704325621 | K132415 | 000 |
| 24026704325614 | K132415 | 000 |
| 44026704325274 | K132415 | 000 |
| 24026704325331 | K132415 | 000 |
| 24026704325324 | K132415 | 000 |
| 44026704325311 | K132415 | 000 |
| 24026704325300 | K132415 | 000 |
| 44026704325298 | K132415 | 000 |
| 44026704325281 | K132415 | 000 |
| 24026704325263 | K132415 | 000 |
| 24026704325256 | K132415 | 000 |
| 44026704325243 | K132415 | 000 |
| 24026704325638 | K132415 | 000 |
| 44026704325649 | K132415 | 000 |
| 44026704325656 | K132415 | 000 |
| 44026704196676 | K132415 | 000 |
| 44026704196669 | K132415 | 000 |
| 44026704196652 | K132415 | 000 |
| 44026704196645 | K132415 | 000 |
| 44026704196638 | K132415 | 000 |
| 44026704196621 | K132415 | 000 |
| 24026704196610 | K132415 | 000 |
| 24026704196603 | K132415 | 000 |
| 24026704196597 | K132415 | 000 |
| 24026704196580 | K132415 | 000 |
| 24026704325676 | K132415 | 000 |
| 24026704325669 | K132415 | 000 |
| 44026704325236 | K132415 | 000 |