The following data is part of a premarket notification filed by Pyng Medical Corp. with the FDA for Fast1 Intraosseous Infusion System.
| Device ID | K080865 |
| 510k Number | K080865 |
| Device Name: | FAST1 INTRAOSSEOUS INFUSION SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | PYNG MEDICAL CORP. #7-13511 CRESTWOOD PL Richmond, B.c., CA V6v 2e9 |
| Contact | Maya Butterfield |
| Correspondent | Maya Butterfield PYNG MEDICAL CORP. #7-13511 CRESTWOOD PL Richmond, B.c., CA V6v 2e9 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-28 |
| Decision Date | 2008-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14026704628671 | K080865 | 000 |