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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K870027
Device Name HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER
Applicant
Salter Labs
P.O. Box 608
Arvin,  CA  93203
Applicant Contact JAMES N CURTI
Correspondent
Salter Labs
P.O. Box 608
Arvin,  CA  93203
Correspondent Contact JAMES N CURTI
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received01/05/1987
Decision Date 03/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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