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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 K800562
Device Name DISPOSABLE HAND HELD NEBULIZER
Applicant
Intec Medical, Inc.
22200 E. 40 Hwy.
Blue Springs,  MO  64015
Applicant Contact J.W. Brown
Correspondent
Intec Medical, Inc.
22200 E. 40 Hwy.
Blue Springs,  MO  64015
Correspondent Contact J.W. Brown
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/12/1980
Decision Date 03/25/1980
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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