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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 K881644
Device Name HUMID-VENT 2 S
Applicant
GIBECK RESPIRATION
165 E. COMMERCE DR.
SHAUMBURG,  IL  60173
Applicant Contact DARRYL LUSTIG
Correspondent
GIBECK RESPIRATION
165 E. COMMERCE DR.
SHAUMBURG,  IL  60173
Correspondent Contact DARRYL LUSTIG
Regulation Number868.5375
Classification Product Code
BYD  
Date Received04/15/1988
Decision Date 06/10/1988
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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