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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, gas-scavenging
510(k) Number K852772
Device Name GAS EVACUATION ACCESSORY
Applicant
SIEMENS ELEMA AB
2360 NORTH PALMER DR.
P.O. BOX 94517
SCHAUMBURG,  IL  60195
Applicant Contact CHRISTER HELLSTEN
Correspondent
SIEMENS ELEMA AB
2360 NORTH PALMER DR.
P.O. BOX 94517
SCHAUMBURG,  IL  60195
Correspondent Contact CHRISTER HELLSTEN
Regulation Number868.5430
Classification Product Code
CBN  
Date Received06/27/1985
Decision Date 10/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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