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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 K913000
Device Name HEART NEBULIZER POLE CLAMP
Applicant
B&B Medical Technologies, Inc.
P.O. Box 1503
Orangevale,  CA  95662
Applicant Contact STEPHEN W BRIGGS
Correspondent
B&B Medical Technologies, Inc.
P.O. Box 1503
Orangevale,  CA  95662
Correspondent Contact STEPHEN W BRIGGS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/08/1991
Decision Date 08/02/1991
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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