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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 ROAD
SOUND BEACH,  NY  11789 -1734
Applicant Contact RICHARD LANZILLOTTO
Correspondent
NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP.
30 NORTHPORT ROAD
SOUND BEACH,  NY  11789 -1734
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
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