MODIFICATION TO OPTICAL SEPARATOR SYSTEM

Laparoscope, General & Plastic Surgery

APPLIED MEDICAL RESOURCES CORP.

The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Modification To Optical Separator System.

Pre-market Notification Details

Device IDK041795
510k NumberK041795
Device Name:MODIFICATION TO OPTICAL SEPARATOR SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactCheryl Blake
CorrespondentCheryl Blake
APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-02
Decision Date2004-09-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.