The following data is part of a premarket notification filed by Sam® Medical Products, Inc. with the FDA for Sam Io Intraosseous Access System.
| Device ID | K191488 |
| 510k Number | K191488 |
| Device Name: | SAM IO Intraosseous Access System |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SAM® Medical Products, Inc. 27350 SW 95th Ave, Suite 3038 Wilsonville, OR 97070 |
| Contact | Jeff Lipps |
| Correspondent | Michelle Lott Lean RAQA, LLC 12602 North Summerwind Drive Marana, AZ 85658 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-04 |
| Decision Date | 2019-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20822045000289 | K191488 | 000 |
| 30822045000293 | K191488 | 000 |
| 20822045000272 | K191488 | 000 |
| 10822045000329 | K191488 | 000 |
| 20822045000296 | K191488 | 000 |
| 10822045000282 | K191488 | 000 |
| 00822045000278 | K191488 | 000 |
| 10822045000244 | K191488 | 000 |
| 00850056748018 | K191488 | 000 |