MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET

Insufflator, Laparoscopic

PALL MEDICAL

The following data is part of a premarket notification filed by Pall Medical with the FDA for Modification To Laparoshield Conditioned Insufflation Set.

Pre-market Notification Details

Device IDK033991
510k NumberK033991
Device Name:MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
ClassificationInsufflator, Laparoscopic
Applicant PALL MEDICAL 555 THIRTEENTH STREET, N.W. Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
PALL MEDICAL 555 THIRTEENTH STREET, N.W. Washington,  DC  20004
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-23
Decision Date2004-01-22
Summary:summary

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