The following data is part of a premarket notification filed by Augustine Medical, Inc. with the FDA for Augustine Guide(tm) Kit.
| Device ID | K912690 |
| 510k Number | K912690 |
| Device Name: | AUGUSTINE GUIDE(TM) KIT |
| Classification | Stylet, Tracheal Tube |
| Applicant | AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Contact | Scott D Augustine |
| Correspondent | Scott D Augustine AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1991-09-04 |