The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Flow Control Unit.
| Device ID | K001904 |
| 510k Number | K001904 |
| Device Name: | ARTHROCARE FLOW CONTROL UNIT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
| Contact | Bruce Prothro |
| Correspondent | Bruce Prothro ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-22 |
| Decision Date | 2000-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470011401 | K001904 | 000 |
| 00817470011326 | K001904 | 000 |
| 00817470011296 | K001904 | 000 |
| 00817470004069 | K001904 | 000 |
| 00817470002515 | K001904 | 000 |