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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K874082
Device Name PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT
Applicant
800-AIR-WATS, INC.
3305 STEED DR.
FLORISSANT,  MO  63033
Applicant Contact VIOLA Y WEIBLE
Correspondent
800-AIR-WATS, INC.
3305 STEED DR.
FLORISSANT,  MO  63033
Correspondent Contact VIOLA Y WEIBLE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/07/1987
Decision Date 12/23/1987
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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