The following data is part of a premarket notification filed by Life Shield Healthcare Products, Inc. with the FDA for Guedel Airways.
| Device ID | K932561 |
| 510k Number | K932561 |
| Device Name: | GUEDEL AIRWAYS |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | LIFE SHIELD HEALTHCARE PRODUCTS, INC. 15381 STONY CREEK WAY Noblesville, IN 46060 |
| Contact | Timothy Struthers |
| Correspondent | Timothy Struthers LIFE SHIELD HEALTHCARE PRODUCTS, INC. 15381 STONY CREEK WAY Noblesville, IN 46060 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-27 |
| Decision Date | 1993-07-22 |