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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 K944194
Device Name DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME
Applicant
MED-TEK INNOVATIONS, INC.
1223 SOUTH 23 ST.
MILWAUKEE,  WI  53204
Applicant Contact ALAN WHITMARSH
Correspondent
MED-TEK INNOVATIONS, INC.
1223 SOUTH 23 ST.
MILWAUKEE,  WI  53204
Correspondent Contact ALAN WHITMARSH
Regulation Number868.5375
Classification Product Code
BYD  
Date Received08/29/1994
Decision Date 09/13/1994
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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