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 |