The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Controllers (system 2000,1100,1200), Model H2076-00, H2079-00, H3000-00, H4000-00;.
| Device ID | K080282 |
| 510k Number | K080282 |
| Device Name: | ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; |
| 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 | 2008-02-04 |
| Decision Date | 2008-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470005479 | K080282 | 000 |
| 00817470005462 | K080282 | 000 |
| 00817470004380 | K080282 | 000 |
| 00817470004373 | K080282 | 000 |
| 00817470003116 | K080282 | 000 |
| 00817470003109 | K080282 | 000 |