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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 K014056
Device Name SALTER LABS MODIFIED NEBUTECH NEBULIZER
Applicant
SALTER LABS
100 W. SYCAMORE RD.
ARVIN,  CA  93203
Applicant Contact DUANE KAZAL
Correspondent
SALTER LABS
100 W. SYCAMORE RD.
ARVIN,  CA  93203
Correspondent Contact DUANE KAZAL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/10/2001
Decision Date 02/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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