The following data is part of a premarket notification filed by Haemotronic, Inc. with the FDA for Haemotrol Model #ht-sb/6 Burette Set.
| Device ID | K921594 |
| 510k Number | K921594 |
| Device Name: | HAEMOTROL MODEL #HT-SB/6 BURETTE SET |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| 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 |