The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Continuous Wave Iii Arthoscopy Pump, Model Ar-6475.
| Device ID | K024291 |
| 510k Number | K024291 |
| Device Name: | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 |
| Classification | Arthroscope |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Sally Foust |
| Correspondent | Sally Foust ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-24 |
| Decision Date | 2003-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888867039346 | K024291 | 000 |