The following data is part of a premarket notification filed by Green Field Medical Sourcing, Inc. with the FDA for Fasttrach Single-pass Tracheal/esophageal Airway System.
| Device ID | K971348 |
| 510k Number | K971348 |
| Device Name: | FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM |
| Classification | Airway, Esophageal (obturator) |
| Applicant | GREEN FIELD MEDICAL SOURCING, INC. 910 BOSTON TURNPIKE RD. Shrewsbury, MA 01545 |
| Contact | Donald R Gorsuch |
| Correspondent | Donald R Gorsuch GREEN FIELD MEDICAL SOURCING, INC. 910 BOSTON TURNPIKE RD. Shrewsbury, MA 01545 |
| Product Code | CAO |
| CFR Regulation Number | 868.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1998-02-27 |