The following data is part of a premarket notification filed by Pyng Medical Corp. with the FDA for Fastx Sternal Intraosseous Device.
| Device ID | K100124 |
| 510k Number | K100124 |
| Device Name: | FASTX STERNAL INTRAOSSEOUS DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | PYNG MEDICAL CORP. 1351 CRESTWOOD PLACE UNIT 7 Richmond, Bc, CA V6v 2e9 |
| Contact | Maya Butterfield |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-01-19 |
| Decision Date | 2010-08-31 |
| Summary: | summary |