The following data is part of a premarket notification filed by Visionsense, Ltd. with the FDA for Vs3.
| Device ID | K123467 |
| 510k Number | K123467 |
| Device Name: | VS3 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | VISIONSENSE, LTD. 555 13TH STREET, NW Washington, DC 20004 |
| Contact | Gerard J Prud'homme |
| Correspondent | Gerard J Prud'homme VISIONSENSE, LTD. 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-09 |
| Decision Date | 2013-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18130400103199 | K123467 | 000 |
| 18130400103052 | K123467 | 000 |
| 18130400103045 | K123467 | 000 |