The following data is part of a premarket notification filed by Green Field Medical Sourcing, Inc. with the FDA for Medport Emergency Medication Airway Tube Adapter.
| Device ID | K971759 |
| 510k Number | K971759 |
| Device Name: | MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER |
| Classification | Tube, Tracheal (w/wo Connector) |
| 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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1998-03-02 |