The following data is part of a premarket notification filed by Intuit Medical Products, Llc with the FDA for Dillard Airway Dilatation System.
| Device ID | K153484 |
| 510k Number | K153484 |
| Device Name: | Dillard Airway Dilatation System |
| Classification | Bronchoscope Accessory |
| Applicant | INTUIT MEDICAL PRODUCTS, LLC 6018 EAGLES REST TRAIL Sugar Hill, GA 30518 |
| Contact | Jack Griffis |
| Correspondent | Jack Griffis INTUIT MEDICAL PRODUCTS, LLC 6018 EAGLES REST TRAIL Sugar Hill, GA 30518 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-03 |
| Decision Date | 2016-07-27 |
| Summary: | summary |