The following data is part of a premarket notification filed by Medtronic Hemotec, Inc. with the FDA for Platelet Function Test Assay Cartridges For The Hepcon Hms.
| Device ID | K954202 |
| 510k Number | K954202 |
| Device Name: | PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | MEDTRONIC HEMOTEC, INC. 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Contact | Adrian Wilson |
| Correspondent | Adrian Wilson MEDTRONIC HEMOTEC, INC. 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-07 |
| Decision Date | 1996-06-20 |
| Summary: | summary |