The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Esophageal Obturator/tracheal Tube.
| Device ID | K875226 |
| 510k Number | K875226 |
| Device Name: | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE |
| Classification | Airway, Esophageal (obturator) |
| Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Contact | John Steen |
| Correspondent | John Steen SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Product Code | CAO |
| CFR Regulation Number | 868.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521105571 | K875226 | 000 |
| 10884521103641 | K875226 | 000 |
| 30884521103638 | K875226 | 000 |
| 40884521105530 | K875226 | 000 |
| 30884521105557 | K875226 | 000 |
| 10884521103634 | K875226 | 000 |
| 20884521103648 | K875226 | 000 |
| 10884521105539 | K875226 | 000 |
| 10884521105553 | K875226 | 000 |
| 10884521105560 | K875226 | 000 |
| 10884521105577 | K875226 | 000 |
| 30884521103621 | K875226 | 000 |
| 30884521105564 | K875226 | 000 |
| 20884521103624 | K875226 | 000 |