FISSO HOLDING SYSTEM

Laparoscope, General & Plastic Surgery

BAITELLA AG

The following data is part of a premarket notification filed by Baitella Ag with the FDA for Fisso Holding System.

Pre-market Notification Details

Device IDK070509
510k NumberK070509
Device Name:FISSO HOLDING SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant BAITELLA AG AMSTEL 320-I Amsterdam,  NL 1017ap
ContactAngelika Scherp
CorrespondentAngelika Scherp
BAITELLA AG AMSTEL 320-I Amsterdam,  NL 1017ap
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-22
Decision Date2007-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M274620WHS8001 K070509 000

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