The following data is part of a premarket notification filed by Save-t-breath Distributors C.c. with the FDA for Stb Guedel Airway.
| Device ID | K933760 |
| 510k Number | K933760 |
| Device Name: | STB GUEDEL AIRWAY |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | SAVE-T-BREATH DISTRIBUTORS C.C. P.O.BOX 87523 HOUGHTON 2041 South Africa, ZA |
| Contact | C. Nates |
| Correspondent | C. Nates SAVE-T-BREATH DISTRIBUTORS C.C. P.O.BOX 87523 HOUGHTON 2041 South Africa, ZA |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-03 |
| Decision Date | 1994-03-23 |