The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Ent Plasma Wand.
| Device ID | K070374 |
| 510k Number | K070374 |
| Device Name: | ARTHROCARE ENT PLASMA WAND |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-08 |
| Decision Date | 2007-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470007473 | K070374 | 000 |
| 00817470003871 | K070374 | 000 |
| 00817470003734 | K070374 | 000 |
| 00817470003185 | K070374 | 000 |
| 00817470002096 | K070374 | 000 |
| 00817470000597 | K070374 | 000 |
| 00817470000542 | K070374 | 000 |
| 00817470000450 | K070374 | 000 |
| 00817470000443 | K070374 | 000 |
| 00817470000368 | K070374 | 000 |
| 00817470003888 | K070374 | 000 |
| 00817470004007 | K070374 | 000 |
| 00817470004151 | K070374 | 000 |
| 00817470006186 | K070374 | 000 |
| 00817470005455 | K070374 | 000 |
| 00817470004595 | K070374 | 000 |
| 00817470004335 | K070374 | 000 |
| 00817470004328 | K070374 | 000 |
| 00817470004311 | K070374 | 000 |
| 00817470004243 | K070374 | 000 |
| 00817470004212 | K070374 | 000 |
| 00817470004199 | K070374 | 000 |
| 00817470000313 | K070374 | 000 |