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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 K840399
Device Name FOAM NOSE
Applicant
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5375
Classification Product Code
BYD  
Date Received01/30/1984
Decision Date 03/16/1984
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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