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 |