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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 K840398
Device Name INLINE FOAM NOSE
Applicant
MALLINCKRODT CRITICAL CARE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MALLINCKRODT CRITICAL CARE
4221 Richmond Rd., N.W.
Walker,  MI  49534
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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