The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Module: Nova Nucleus Tmg Module Fluid Pack.
| Device ID | K912321 |
| 510k Number | K912321 |
| Device Name: | MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK |
| Classification | Photometric Method, Magnesium |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul Macdonald |
| Correspondent | Paul Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1991-06-17 |