The following data is part of a premarket notification filed by Global Blood Resources, Llc with the FDA for Hemobag, Model Hbbsd2000.
| Device ID | K031150 |
| 510k Number | K031150 |
| Device Name: | HEMOBAG, MODEL HBBSD2000 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | GLOBAL BLOOD RESOURCES, LLC 998 WINDSOR AVE. Windsor, CT 06095 |
| Contact | Keith Samolyk |
| Correspondent | Keith Samolyk GLOBAL BLOOD RESOURCES, LLC 998 WINDSOR AVE. Windsor, CT 06095 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-10 |
| Decision Date | 2003-06-23 |
| Summary: | summary |