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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 K983403
Device Name SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
Applicant
SALTER LABS
100 WEST SYCAMORE RD.
ARVIN,  CA  93203
Applicant Contact DUANE KAZAL
Correspondent
SALTER LABS
100 WEST SYCAMORE RD.
ARVIN,  CA  93203
Correspondent Contact DUANE KAZAL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/27/1998
Decision Date 12/17/1998
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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