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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 K992986
Device Name SALTER LABS SINGLE PATIENT USE 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 Received09/03/1999
Decision Date 09/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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