The following data is part of a premarket notification filed by Pyng Medical Corp. with the FDA for F.a.s.t. 1 Intraosseous Infusion System.
| Device ID | K970380 |
| 510k Number | K970380 |
| Device Name: | F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | PYNG MEDICAL CORP. 2660 OAK ST. Vancouver, CA V6h 3z6 |
| Contact | David L Johnson |
| Correspondent | David L Johnson PYNG MEDICAL CORP. 2660 OAK ST. Vancouver, CA V6h 3z6 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-04-25 |
| Summary: | summary |