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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 K930252
Device Name BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)
Applicant
BIRD LIFE DESIGN
2735 EAST BELT LINE RD.
CARROLLTON,  TX  75006
Applicant Contact ALLEN
Correspondent
BIRD LIFE DESIGN
2735 EAST BELT LINE RD.
CARROLLTON,  TX  75006
Correspondent Contact ALLEN
Regulation Number868.5240
Classification Product Code
CAI  
Date Received01/08/1993
Decision Date 02/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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