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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 K900228
Device Name H.E.A.R.T. NEBULIZER
Applicant
B&B Medical Technologies, Inc.
3569 Recycle Rd., Suite 16
Rancho Cordova,  CA  95670
Applicant Contact W BRIGGS,III
Correspondent
B&B Medical Technologies, Inc.
3569 Recycle Rd., Suite 16
Rancho Cordova,  CA  95670
Correspondent Contact W BRIGGS,III
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/17/1990
Decision Date 03/16/1990
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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