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 |