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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 K925543
Device Name BLD-18000 SERIES HEATED BREATHING CIRCUIT
Applicant
BIRD LIFE DESIGN
2735 EAST BELT LINE RD.
CARROLLTON,  TX  75006
Applicant Contact JAMES ANTOSH
Correspondent
BIRD LIFE DESIGN
2735 EAST BELT LINE RD.
CARROLLTON,  TX  75006
Correspondent Contact JAMES ANTOSH
Regulation Number868.5240
Classification Product Code
CAI  
Date Received11/05/1992
Decision Date 04/30/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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