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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 K931487
Device Name BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE
Applicant
Bird Life Design
2735 E. Beltline Rd.
Carrollton,  TX  75006
Applicant Contact JAMES ANTOSH
Correspondent
Bird Life Design
2735 E. Beltline Rd.
Carrollton,  TX  75006
Correspondent Contact JAMES ANTOSH
Regulation Number868.5240
Classification Product Code
CAI  
Date Received03/24/1993
Decision Date 12/16/1993
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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