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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 K933641
Device Name BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE
Applicant
Bird Life Design
4450 Alpha Rd.
Dallas,  TX  75244
Applicant Contact REBECCA D FULLER
Correspondent
Bird Life Design
4450 Alpha Rd.
Dallas,  TX  75244
Correspondent Contact REBECCA D FULLER
Regulation Number868.5240
Classification Product Code
CAI  
Date Received07/27/1993
Decision Date 10/15/1993
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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