The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Sinus Dilation System With Cannulated Instrument.
| Device ID | K131709 |
| 510k Number | K131709 |
| Device Name: | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ARTHROCARE CORP. 7000 W.WILLIAM CANNON DRIVE BUILDING ONE Austin, TX 78735 |
| Contact | Ashley Dawson |
| Correspondent | Ashley Dawson ARTHROCARE CORP. 7000 W.WILLIAM CANNON DRIVE BUILDING ONE Austin, TX 78735 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-11 |
| Decision Date | 2013-10-04 |
| Summary: | summary |