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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 K872153
Device Name STOM-VENT
Applicant
GIBECK RESPIRATION
8600 W. BRYN MAWR
SUITE 200N
CHICAGO,  IL  60631
Applicant Contact DARRYL LUSTIG
Correspondent
GIBECK RESPIRATION
8600 W. BRYN MAWR
SUITE 200N
CHICAGO,  IL  60631
Correspondent Contact DARRYL LUSTIG
Regulation Number868.5375
Classification Product Code
BYD  
Date Received06/04/1987
Decision Date 08/03/1987
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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