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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 K961476
Device Name SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
Applicant
Salter Labs
100 W. Sycamore Rd.
Arvin,  CA  93203
Applicant Contact JAMES N CURTI
Correspondent
Salter Labs
100 W. Sycamore Rd.
Arvin,  CA  93203
Correspondent Contact JAMES N CURTI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/18/1996
Decision Date 07/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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