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 |