3-CCD DIGITAL CAMERA SYSTEM

Laparoscope, General & Plastic Surgery

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for 3-ccd Digital Camera System.

Pre-market Notification Details

Device IDK031098
510k NumberK031098
Device Name:3-CCD DIGITAL CAMERA SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactLaura D Seneff
CorrespondentLaura D Seneff
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-07
Decision Date2003-06-04
Summary:summary

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