The following data is part of a premarket notification filed by Haemotronic, Inc. with the FDA for Y-type Blood Administration Set Model #ht-tr2.
Device ID | K921595 |
510k Number | K921595 |
Device Name: | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 |
Classification | Set, Blood Transfusion |
Applicant | HAEMOTRONIC, INC. 45 KULICK RD. Fairfield, NJ 07004 |
Contact | Willer Ghelfi |
Correspondent | Willer Ghelfi HAEMOTRONIC, INC. 45 KULICK RD. Fairfield, NJ 07004 |
Product Code | BRZ |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-03 |
Decision Date | 1992-12-24 |