The following data is part of a premarket notification filed by Spectral Medical Inc. with the FDA for Sam Crrt Unit, Sam Cassette Crrt.
| Device ID | K170790 |
| 510k Number | K170790 |
| Device Name: | SAM CRRT Unit, SAM Cassette CRRT |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Spectral Medical Inc. 135 The West Mall, Unit 2 Toronto, CA M9c 1c2 |
| Contact | Danijela Domljanovic |
| Correspondent | Olga Pavlova Amarex Clinical Research 20201 Century Boulevard, 4th Floor Germantown, MD 20874 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-16 |
| Decision Date | 2017-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540161930011 | K170790 | 000 |