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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 K903580
Device Name MICRO-MISTER
Applicant
Bp , Ltd.
P.O. Box 3052
Middletown,  NY  10940
Applicant Contact BORDONI
Correspondent
Bp , Ltd.
P.O. Box 3052
Middletown,  NY  10940
Correspondent Contact BORDONI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/08/1990
Decision Date 12/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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