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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854036
Device Name MANUAL VENTILATION ACCESSORY
Applicant
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Applicant Contact CHRISTER HELLSTEN
Correspondent
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Correspondent Contact CHRISTER HELLSTEN
Date Received08/27/1985
Decision Date 10/23/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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