The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Aspirate Kit.
| Device ID | K062365 |
| 510k Number | K062365 |
| Device Name: | ARTHREX ASPIRATE KIT |
| Classification | Syringe, Piston |
| 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 | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-14 |
| Decision Date | 2006-09-29 |
| Summary: | summary |