The following data is part of a premarket notification filed by Edwards Orthopaedics Div., Baxter Healthcare Corp. with the FDA for Irrigation Set.
| Device ID | K883300 |
| 510k Number | K883300 |
| Device Name: | IRRIGATION SET |
| Classification | Arthroscope |
| Applicant | EDWARDS ORTHOPAEDICS DIV., BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 -1150 |
| Contact | Ronald L Dieck |
| Correspondent | Ronald L Dieck EDWARDS ORTHOPAEDICS DIV., BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 -1150 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-04 |
| Decision Date | 1988-11-01 |