The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Arthrocare Head And Neck Coblation Wand.
| Device ID | K131205 |
| 510k Number | K131205 |
| Device Name: | ARTHROCARE HEAD AND NECK COBLATION WAND |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-29 |
| Decision Date | 2013-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470006445 | K131205 | 000 |