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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 K874597
Device Name THERMOVENT 600, 1200, T, 02
Applicant
PORTEX, INC.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Applicant Contact EDWIN G GROVE
Correspondent
PORTEX, INC.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Correspondent Contact EDWIN G GROVE
Regulation Number868.5375
Classification Product Code
BYD  
Date Received11/09/1987
Decision Date 01/19/1988
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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