The following data is part of a premarket notification filed by Conmed Corporation with the FDA for True Hd 3mos Camera System.
| Device ID | K161017 |
| 510k Number | K161017 |
| Device Name: | True HD 3MOS Camera System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CONMED CORPORATION 525 FRENCH ROAD Utica, NY 13502 |
| Contact | Diair Cantisani |
| Correspondent | Diair Cantisani CONMED CORPORATION 525 FRENCH ROAD Utica, NY 13502 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-12 |
| Decision Date | 2016-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854080607 | K161017 | 000 |