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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K911336
Device Name BIRD NEBULIZATION SYNCHRONIZER
Applicant
Bird Products Corp.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Applicant Contact W. C BENTINCK
Correspondent
Bird Products Corp.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Correspondent Contact W. C BENTINCK
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/26/1991
Decision Date 11/29/1991
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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