The following data is part of a premarket notification filed by Ffrench Pocket Emergency Airway, Inc. with the FDA for Key Chain Emergency Airway.
| Device ID | K962312 |
| 510k Number | K962312 |
| Device Name: | KEY CHAIN EMERGENCY AIRWAY |
| Classification | Needle, Emergency Airway |
| Applicant | FFRENCH POCKET EMERGENCY AIRWAY, INC. 1705 CALHOUN ST. New Orleans, LA 70118 |
| Contact | H. Clay Wilson, P.e. |
| Correspondent | H. Clay Wilson, P.e. FFRENCH POCKET EMERGENCY AIRWAY, INC. 1705 CALHOUN ST. New Orleans, LA 70118 |
| Product Code | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1997-06-17 |