The following data is part of a premarket notification filed by Migada Plant with the FDA for Tba.
| Device ID | K121269 |
| 510k Number | K121269 |
| Device Name: | TBA |
| Classification | Set, Administration, Intravascular |
| Applicant | MIGADA PLANT NORTH INDUSTRIAL ZONE Kiryat Shmona, IL 10258 |
| Contact | Yossi Shachar |
| Correspondent | Yossi Shachar MIGADA PLANT NORTH INDUSTRIAL ZONE Kiryat Shmona, IL 10258 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-26 |
| Decision Date | 2013-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27298119121205 | K121269 | 000 |