MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM

Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)

NDO SURGICAL, INC.

The following data is part of a premarket notification filed by Ndo Surgical, Inc. with the FDA for Modification To Endoscopic Plication System.

Pre-market Notification Details

Device IDK032820
510k NumberK032820
Device Name:MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
ClassificationEndoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
Applicant NDO SURGICAL, INC. 125 HIGH ST., SUITE 7 Mansfield,  MA  02048
ContactEric Bannon
CorrespondentEric Bannon
NDO SURGICAL, INC. 125 HIGH ST., SUITE 7 Mansfield,  MA  02048
Product CodeODE  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-10
Decision Date2003-10-23
Summary:summary

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