The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mil Cm-ii Coagulation Machine.
| Device ID | K913320 |
| 510k Number | K913320 |
| Device Name: | MIL CM-II COAGULATION MACHINE |
| Classification | Timer, Clot, Automated |
| Applicant | MEDICAL INNOVATIONS CORP. 13-B, EDWARD MANSION 141 PRINCE EDWARD ROAD Kowloon, Hong Kong, HK |
| Contact | Raymond Chan |
| Correspondent | Raymond Chan MEDICAL INNOVATIONS CORP. 13-B, EDWARD MANSION 141 PRINCE EDWARD ROAD Kowloon, Hong Kong, HK |
| Product Code | GKN |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-25 |
| Decision Date | 1992-06-16 |