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 |