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 |