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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condenser, heat and moisture (artificial nose)
510(k) Number K943915
Device Name HEAT AND MOISTURE EXCHANGER FILTER (HME)
Applicant
MEDICOMP, INC.
11873 FLINTWOOD STREET, N.E.
COON RAPIDS,  MN  55448
Applicant Contact DUNCAN G JOHNSON
Correspondent
MEDICOMP, INC.
11873 FLINTWOOD STREET, N.E.
COON RAPIDS,  MN  55448
Correspondent Contact DUNCAN G JOHNSON
Regulation Number868.5375
Classification Product Code
BYD  
Date Received08/11/1994
Decision Date 10/14/1994
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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