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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 K913095
Device Name SAM LS
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
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