SUTURE CLINCH

Laparoscope, General & Plastic Surgery

APPLIED MEDICAL RESOURCES

The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Suture Clinch.

Pre-market Notification Details

Device IDK992852
510k NumberK992852
Device Name:SUTURE CLINCH
ClassificationLaparoscope, General & Plastic Surgery
Applicant APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
ContactAnil Bhalani
CorrespondentAnil Bhalani
APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-24
Decision Date1999-11-22
Summary:summary

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