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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 K962879
Device Name SALTERLABS 8660 SERIES NEBULIZER
Applicant
SALTER LABS
100 WEST SYCAMORE RD.
ARVIN,  CA  93203
Applicant Contact JAMES N CURTI
Correspondent
SALTER LABS
100 WEST SYCAMORE RD.
ARVIN,  CA  93203
Correspondent Contact JAMES N CURTI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/24/1996
Decision Date 10/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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