INSITE MODEL 20 & MODEL 15 INSUFFLATORS

Insufflator, Laparoscopic

ANDRONIC DEVICES, LTD.

The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Insite Model 20 & Model 15 Insufflators.

Pre-market Notification Details

Device IDK934926
510k NumberK934926
Device Name:INSITE MODEL 20 & MODEL 15 INSUFFLATORS
ClassificationInsufflator, Laparoscopic
Applicant ANDRONIC DEVICES, LTD. SUITE 140 13120 VANIER PLACE Richmond, B.c. Canada V6v 2j2,  CA V6v 2j2
ContactRobert Macneil
CorrespondentRobert Macneil
ANDRONIC DEVICES, LTD. SUITE 140 13120 VANIER PLACE Richmond, B.c. Canada V6v 2j2,  CA V6v 2j2
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-14
Decision Date1994-05-26

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