The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Cuff Sentry.
| Device ID | K102674 |
| 510k Number | K102674 |
| Device Name: | CUFF SENTRY |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | VENTLAB CORP. 155 BOYCE DRIVE Mocksville, NC 27028 |
| Contact | James Cochie |
| Correspondent | James Cochie VENTLAB CORP. 155 BOYCE DRIVE Mocksville, NC 27028 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-16 |
| Decision Date | 2011-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889483002599 | K102674 | 000 |