The following data is part of a premarket notification filed by Intl. Medical Devices Ltd. with the FDA for Re-trake Weiss Emergency Airway & Thoracic System.
| Device ID | K862909 |
| 510k Number | K862909 |
| Device Name: | RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | INTL. MEDICAL DEVICES LTD. 19355 BUSINESS CENTER DR. SUITE 8 Northridge, CA 91324 |
| Contact | Marcia Weiss |
| Correspondent | Marcia Weiss INTL. MEDICAL DEVICES LTD. 19355 BUSINESS CENTER DR. SUITE 8 Northridge, CA 91324 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-31 |
| Decision Date | 1986-09-09 |