The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Truehd (1080p) Digital Camera System.
| Device ID | K063457 |
| 510k Number | K063457 |
| Device Name: | TRUEHD (1080P) DIGITAL CAMERA SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Elizabeth Paul |
| Correspondent | Elizabeth Paul CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2006-12-05 |
| Summary: | summary |