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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 K941535
Device Name TRACHEOLIFE
Applicant
MALLINCKRODT MEDICAL
R.D. #1 BOX 1173
HOOK ROAD
ARGYLE,  NY  12809
Applicant Contact FRANK STECIUK
Correspondent
MALLINCKRODT MEDICAL
R.D. #1 BOX 1173
HOOK ROAD
ARGYLE,  NY  12809
Correspondent Contact FRANK STECIUK
Regulation Number868.5375
Classification Product Code
BYD  
Date Received03/30/1994
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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