The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Arthrowands.
| Device ID | K033584 |
| 510k Number | K033584 |
| Device Name: | ARTHROCARE ARTHROWANDS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Contact | Valerie Defiesta-ng |
| Correspondent | Valerie Defiesta-ng ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-13 |
| Decision Date | 2003-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470006520 | K033584 | 000 |
| 00817470003123 | K033584 | 000 |
| 00817470002126 | K033584 | 000 |
| 00817470001921 | K033584 | 000 |
| 00817470001914 | K033584 | 000 |
| 00817470001907 | K033584 | 000 |
| 00817470001860 | K033584 | 000 |
| 00817470001853 | K033584 | 000 |
| 00817470001839 | K033584 | 000 |
| 00817470001716 | K033584 | 000 |
| 00817470003314 | K033584 | 000 |
| 00817470003512 | K033584 | 000 |
| 00817470006421 | K033584 | 000 |
| 00817470006261 | K033584 | 000 |
| 00817470004854 | K033584 | 000 |
| 00817470004700 | K033584 | 000 |
| 00817470004564 | K033584 | 000 |
| 00817470004557 | K033584 | 000 |
| 00817470004540 | K033584 | 000 |
| 00817470004533 | K033584 | 000 |
| 00817470003550 | K033584 | 000 |
| 00817470000696 | K033584 | 000 |