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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K850926
Device Name MICRON ONE PORTA. ULTRASONIC NEBULIZER
Applicant
ENDOTEK DEVELOPMENT LABORATORIES
417 WAKARA WAY
SALT LAKE CITY,  UT  84108
Applicant Contact MARK R COLLINS
Correspondent
ENDOTEK DEVELOPMENT LABORATORIES
417 WAKARA WAY
SALT LAKE CITY,  UT  84108
Correspondent Contact MARK R COLLINS
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received03/05/1985
Decision Date 05/23/1985
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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