The following data is part of a premarket notification filed by Intuit Medical Products, Llc with the FDA for Dss Sinusplasty Balloon Catheter.
| Device ID | K143738 |
| 510k Number | K143738 |
| Device Name: | DSS Sinusplasty Balloon Catheter |
| Classification | Instrument, Ent Manual Surgical |
| 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 | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-30 |
| Decision Date | 2015-08-27 |
| Summary: | summary |