GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER

System, Gastrointestinal Motility (electrical)

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Gastroplasty Calibrating Tube & Gastrostenometer.

Pre-market Notification Details

Device IDK874690
510k NumberK874690
Device Name:GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
ClassificationSystem, Gastrointestinal Motility (electrical)
Applicant MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
ContactLynn R Breckenridge
CorrespondentLynn R Breckenridge
MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
Product CodeFFX  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-16
Decision Date1988-02-08

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