The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Hemostasis Managment System Plus (hms-plus).
| Device ID | K111339 |
| 510k Number | K111339 |
| Device Name: | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) |
| Classification | Analyzer, Heparin, Automated |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Amra Racic |
| Correspondent | Amra Racic MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | JOX |
| CFR Regulation Number | 864.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-12 |
| Decision Date | 2011-06-08 |
| Summary: | summary |