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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K041485
Device Name MARPAC MESSENGER MODEL #501
Applicant
Marpac, Inc.
8436 Washington Pl. NE
Albuquerque,  NM  87113
Applicant Contact EVELYN TRUJILLO
Correspondent
Marpac, Inc.
8436 Washington Pl. NE
Albuquerque,  NM  87113
Correspondent Contact EVELYN TRUJILLO
Regulation Number868.5800
Classification Product Code
JOH  
Date Received06/04/2004
Decision Date 08/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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