The following data is part of a premarket notification filed by Agram Export-import Co. with the FDA for Agram Spyral Electrode.
| Device ID | K934779 |
| 510k Number | K934779 |
| Device Name: | AGRAM SPYRAL ELECTRODE |
| Classification | Electrode, Needle |
| Applicant | AGRAM EXPORT-IMPORT CO. 44 FAIRVIEW AVE. Glen Rock, NJ 07452 -2512 |
| Contact | Goran Komarica |
| Correspondent | Goran Komarica AGRAM EXPORT-IMPORT CO. 44 FAIRVIEW AVE. Glen Rock, NJ 07452 -2512 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-06 |
| Decision Date | 1995-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852373007243 | K934779 | 000 |
| 00852373007212 | K934779 | 000 |
| 00852373007052 | K934779 | 000 |
| 00852373007021 | K934779 | 000 |