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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K040657
Device Name BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80
Applicant
Vygon SA
45900 Parsippany Ct.
Temecula,  CA  92592
Applicant Contact LAETITIA BERNARD
Correspondent
Vygon SA
45900 Parsippany Ct.
Temecula,  CA  92592
Correspondent Contact LAETITIA BERNARD
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/12/2004
Decision Date 06/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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