The following data is part of a premarket notification filed by Tuta Healthcare Pty Limited with the FDA for Blood/solution Administration Set, Model 33.015.
| Device ID | K023039 |
| 510k Number | K023039 |
| Device Name: | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 |
| Classification | Set, Blood Transfusion |
| 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 | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-12 |
| Decision Date | 2002-11-07 |
| Summary: | summary |