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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K013122
Device Name EMS ELECTROSTATIC FLITER AND HME COMBINATION
Applicant
Engineered Medical Systems
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
Engineered Medical Systems
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL DRYDEN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/19/2001
Decision Date 04/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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