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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 K021742
Device Name GALEMED NEB-EASY NEBULIZER
Applicant
Galemed Corp.
29201 Via Norte
Temecula,  CA  92591
Applicant Contact TOM SHANKS
Correspondent
Galemed Corp.
29201 Via Norte
Temecula,  CA  92591
Correspondent Contact TOM SHANKS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/28/2002
Decision Date 10/25/2002
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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