The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Dual Wave Arthroscopy Fluid Management Device.
| Device ID | K083707 |
| 510k Number | K083707 |
| Device Name: | ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE |
| Classification | Arthroscope |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Sally Foust |
| Correspondent | Sally Foust ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-08-03 |
| Summary: | summary |