The following data is part of a premarket notification filed by Pollogen Ltd. with the FDA for Pollogen Legend System.
| Device ID | K173503 |
| 510k Number | K173503 |
| Device Name: | Pollogen Legend System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Pollogen Ltd. 6 Kaufman St. Tel Aviv, IL 6801298 |
| Contact | Einat Shammai |
| Correspondent | Elissa Burg BioVision Ltd Had Nes 183 Had Nes, IL 1295000 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016586275 | K173503 | 000 |
| 07290016586497 | K173503 | 000 |
| 07290016586503 | K173503 | 000 |
| 07290016586510 | K173503 | 000 |
| 07290016586527 | K173503 | 000 |
| 07290016586534 | K173503 | 000 |
| 07290016586121 | K173503 | 000 |
| 07290016586138 | K173503 | 000 |
| 07290016586145 | K173503 | 000 |
| 07290016586152 | K173503 | 000 |
| 07290016586169 | K173503 | 000 |
| 07290016586176 | K173503 | 000 |
| 07290016586206 | K173503 | 000 |
| 07290016586213 | K173503 | 000 |
| 07290016586220 | K173503 | 000 |
| 07290016586268 | K173503 | 000 |
| 17290016586487 | K173503 | 000 |