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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 K091794
Device Name CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
Applicant
STEVE ISLAVA
1599 SUPERIOR AVE, STE B5
COSTA MESA,  CA  92627
Applicant Contact JIM BARLEY
Correspondent
STEVE ISLAVA
1599 SUPERIOR AVE, STE B5
COSTA MESA,  CA  92627
Correspondent Contact JIM BARLEY
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/17/2009
Decision Date 01/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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