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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 K880304
Device Name INSPIRON NEBULO BASIC EXTERNAL HEATER
Applicant
INTERTECH RESOURCES, INC.
333 WEST WACKER DR.
SUITE 1900
CHICAGO,  IL  60606
Applicant Contact SHERYL MARCOUILLER
Correspondent
INTERTECH RESOURCES, INC.
333 WEST WACKER DR.
SUITE 1900
CHICAGO,  IL  60606
Correspondent Contact SHERYL MARCOUILLER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/25/1988
Decision Date 03/04/1988
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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