The following data is part of a premarket notification filed by Haemotronic, Inc. with the FDA for Drain/priming/recirculation Bag.
Device ID | K913361 |
510k Number | K913361 |
Device Name: | DRAIN/PRIMING/RECIRCULATION BAG |
Classification | Accessories, Blood Circuit, Hemodialysis |
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 | KOC |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-29 |
Decision Date | 1992-03-30 |