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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 K940257
Device Name HAND-HELD NEBULIZER
Applicant
Nutec, Inc.
1 S 241 N. Flanders Ln.
Winfield,  IL  60190
Applicant Contact CHARLES F COSENTINO
Correspondent
Nutec, Inc.
1 S 241 N. Flanders Ln.
Winfield,  IL  60190
Correspondent Contact CHARLES F COSENTINO
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/19/1994
Decision Date 10/13/1994
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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