GAS EVACUATION ACCESSORY

Apparatus, Gas-scavenging

SIEMENS ELEMA AB

The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Gas Evacuation Accessory.

Pre-market Notification Details

Device IDK852772
510k NumberK852772
Device Name:GAS EVACUATION ACCESSORY
ClassificationApparatus, Gas-scavenging
Applicant SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg,  IL  60195
ContactChrister Hellsten
CorrespondentChrister Hellsten
SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg,  IL  60195
Product CodeCBN  
CFR Regulation Number868.5430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-27
Decision Date1985-10-10

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