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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 K040439
Device Name MDI TRIGGER GUARD
Applicant
North American Technical Services (Nats) Corp.
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact RICHARD LANZILLOTTO
Correspondent
North American Technical Services (Nats) Corp.
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact RICHARD LANZILLOTTO
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/19/2004
Decision Date 07/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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