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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 K970010
Device Name FPT NEBULIZER
Applicant
Fluid Propulsion Technologies, Inc.
3110 Coronado Dr.
Santa Clara,  CA  95054
Applicant Contact GEORGE JOHNSON
Correspondent
Fluid Propulsion Technologies, Inc.
3110 Coronado Dr.
Santa Clara,  CA  95054
Correspondent Contact GEORGE JOHNSON
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/02/1997
Decision Date 04/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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