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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection And Trap, Breathing System (Uncalibrated)
510(k) Number K925422
Device Name BIRD 1000 PV PORTABLE VENTILATOR
Applicant
Bird Products Corp.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Applicant Contact BENTINCK
Correspondent
Bird Products Corp.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Correspondent Contact BENTINCK
Regulation Number880.6740
Classification Product Code
CBC  
Date Received10/27/1992
Decision Date 05/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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