LM- LAP 10 HIGH FLOW INSUFFLATOR

Insufflator, Laparoscopic

LEISEGANG MEDICAL, INC.

The following data is part of a premarket notification filed by Leisegang Medical, Inc. with the FDA for Lm- Lap 10 High Flow Insufflator.

Pre-market Notification Details

Device IDK914201
510k NumberK914201
Device Name:LM- LAP 10 HIGH FLOW INSUFFLATOR
ClassificationInsufflator, Laparoscopic
Applicant LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton,  FL  33487 -2883
ContactDouglas Kwart
CorrespondentDouglas Kwart
LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton,  FL  33487 -2883
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-19
Decision Date1992-01-09

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