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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 K972371
Device Name ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
Applicant
BRASAMERICA MEDICAL EQUIPMENT, INC.
55 NORTHERN BLVD., SUITE 410
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
BRASAMERICA MEDICAL EQUIPMENT, INC.
55 NORTHERN BLVD., SUITE 410
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/25/1997
Decision Date 08/19/1997
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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