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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 K952036
Device Name FLEXLIFE
Applicant
MALLINCKRODT MEDICAL
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS,  MO  63134
Applicant Contact JAMES C WEBBER
Correspondent
MALLINCKRODT MEDICAL
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS,  MO  63134
Correspondent Contact JAMES C WEBBER
Regulation Number868.5375
Classification Product Code
BYD  
Date Received05/01/1995
Decision Date 06/08/1995
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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