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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K913753
Device Name BODAI NEO2 -SAFE AIRWAY PRESSURE CAP
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 Number868.5240
Classification Product Code
CAI  
Date Received08/21/1991
Decision Date 10/23/1991
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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