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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K964956
Device Name E-Z SPACER MASK (SMALL)
Applicant
Airpharma, LLC
P.O. Box 1142
Ramona,  CA  92065
Applicant Contact TOM EVANGELISTI
Correspondent
Airpharma, LLC
P.O. Box 1142
Ramona,  CA  92065
Correspondent Contact TOM EVANGELISTI
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received12/11/1996
Decision Date 04/23/1997
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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