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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 K913096
Device Name SAM SC
Applicant
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973 -8619
Applicant Contact FRANK FERGUSON
Correspondent
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973 -8619
Correspondent Contact FRANK FERGUSON
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/12/1991
Decision Date 12/03/1992
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
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