The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Cuff Pilot, Sure Seal.
| Device ID | K142103 |
| 510k Number | K142103 |
| Device Name: | CUFF PILOT, SURE SEAL |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-01 |
| Decision Date | 2015-05-08 |
| Summary: | summary |