MIST ENDOSCOPIC CANNULAS

Laparoscope, General & Plastic Surgery

MIST, INC.

The following data is part of a premarket notification filed by Mist, Inc. with the FDA for Mist Endoscopic Cannulas.

Pre-market Notification Details

Device IDK951481
510k NumberK951481
Device Name:MIST ENDOSCOPIC CANNULAS
ClassificationLaparoscope, General & Plastic Surgery
Applicant MIST, INC. 55 NORTHERN BLVD. Great Neck,  NY  11021
ContactCarolann Kotula
CorrespondentCarolann Kotula
MIST, INC. 55 NORTHERN BLVD. Great Neck,  NY  11021
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-30
Decision Date1995-05-03

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