The following data is part of a premarket notification filed by Tuta Healthcare Pty Limited with the FDA for Tuta Healthcare Arthroscopy Flushing Set, Model 80.601.
| Device ID | K020083 |
| 510k Number | K020083 |
| Device Name: | TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 |
| Classification | Arthroscope |
| Applicant | TUTA HEALTHCARE PTY LIMITED 318-332 BURNS BAY ROAD LANE COVE Sydney Nsw, AU 2066 |
| Contact | Omid Souresrafil |
| Correspondent | Omid Souresrafil TUTA HEALTHCARE PTY LIMITED 318-332 BURNS BAY ROAD LANE COVE Sydney Nsw, AU 2066 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-10 |
| Decision Date | 2002-02-12 |
| Summary: | summary |