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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 K781394
Device Name DISPOSABLE INCENTIVE SPIROMETER
Applicant
Inhal-O-Tech Medical Plastic
P.O. Box 385
Blue Springs,  MO  64015
Applicant Contact Joseph W Brown
Correspondent
Inhal-O-Tech Medical Plastic
P.O. Box 385
Blue Springs,  MO  64015
Correspondent Contact Joseph W Brown
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received08/14/1978
Decision Date 10/16/1978
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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