LOW PROFILE GASTROSTOMY

Tubes, Gastrointestinal (and Accessories)

MICROVASIVE

The following data is part of a premarket notification filed by Microvasive with the FDA for Low Profile Gastrostomy.

Pre-market Notification Details

Device IDK872771
510k NumberK872771
Device Name:LOW PROFILE GASTROSTOMY
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant MICROVASIVE 31 MAPLE ST. Milford,  MA  01757
ContactSamuel D Wade
CorrespondentSamuel D Wade
MICROVASIVE 31 MAPLE ST. Milford,  MA  01757
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-14
Decision Date1987-10-09

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