The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for 3-ccd Digital Camera System.
| Device ID | K031098 |
| 510k Number | K031098 |
| Device Name: | 3-CCD DIGITAL CAMERA SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura D Seneff |
| Correspondent | Laura D Seneff LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-07 |
| Decision Date | 2003-06-04 |
| Summary: | summary |