The following data is part of a premarket notification filed by Pyng Medical Corp. with the FDA for Fastresponder Sternal Intraosseous Device.
| Device ID | K130487 |
| 510k Number | K130487 |
| Device Name: | FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | PYNG MEDICAL CORP. 13480 CRESTWOOD PLACE UNIT 210 Richmond, Bc, CA V6v 2j9 |
| Contact | Michele Tyler |
| Correspondent | Michele Tyler PYNG MEDICAL CORP. 13480 CRESTWOOD PLACE UNIT 210 Richmond, Bc, CA V6v 2j9 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704628692 | K130487 | 000 |
| 34026704628699 | K130487 | 000 |
| 34026704628682 | K130487 | 000 |