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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 K980407
Device Name HOPE NEBULIZER
Applicant
B & B MEDICAL TECHNOLOGIES, INC.
3569 RECYCLE RD., SUITE 16
RANCHO CORDOVA,  CA  95670
Applicant Contact STEPHEN W BRIGGS III
Correspondent
B & B MEDICAL TECHNOLOGIES, INC.
3569 RECYCLE RD., SUITE 16
RANCHO CORDOVA,  CA  95670
Correspondent Contact STEPHEN W BRIGGS III
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/03/1998
Decision Date 05/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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