The following data is part of a premarket notification filed by Augustine Medical, Inc. with the FDA for Augustine Intubation Guide(tm).
| Device ID | K882659 |
| 510k Number | K882659 |
| Device Name: | AUGUSTINE INTUBATION GUIDE(TM) |
| Classification | Laryngoscope, Rigid |
| Applicant | AUGUSTINE MEDICAL, INC. 1601 STONECREST COURT Blue Springs, MO 64015 |
| Contact | D Augustine |
| Correspondent | D Augustine AUGUSTINE MEDICAL, INC. 1601 STONECREST COURT Blue Springs, MO 64015 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-28 |
| Decision Date | 1988-07-21 |