The following data is part of a premarket notification filed by Haemotronic, Inc. with the FDA for Cavh/cvvh/cavhd Set Model #ht-hf/505.
Device ID | K921597 |
510k Number | K921597 |
Device Name: | CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 |
Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
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 | FJK |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-03 |
Decision Date | 1995-02-24 |