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 |