The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Arthrocare Nasastent Cmc Nasal Dressing.
Device ID | K140992 |
510k Number | K140992 |
Device Name: | ARTHROCARE NASASTENT CMC NASAL DRESSING |
Classification | Splint, Intranasal Septal |
Applicant | ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
Contact | Mitchell Dhority |
Correspondent | Mitchell Dhority ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
Product Code | LYA |
CFR Regulation Number | 874.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-17 |
Decision Date | 2014-06-16 |
Summary: | summary |