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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 K063449
Device Name DELUXE NEBULIZER
Applicant
Access Point Medical, LLC
835 NW Pebble Beach Way
Beaverton,  OR  97006
Applicant Contact JAMES W SANDBERG
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONROY
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/15/2006
Decision Date 03/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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