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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 Rd.
Argyle,  NY  12809
Applicant Contact FRANK STECIUK
Correspondent
Mallinckrodt Medical
R.D. #1 Box 1173
Hook Rd.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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