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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 K031982
Device Name BIRDSONG LEVERHALER, MODEL LH-1000
Applicant
Birdsong Medical Devices, Inc.
1456 Rt 22
Brewster,  NY  10509
Applicant Contact ERIC FUGELSANG
Correspondent
Birdsong Medical Devices, Inc.
1456 Rt 22
Brewster,  NY  10509
Correspondent Contact ERIC FUGELSANG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/26/2003
Decision Date 04/02/2004
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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