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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 K960795
Device Name VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
Applicant
VYGON CORP.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Applicant Contact ANNE MARIE CESARIO
Correspondent
VYGON CORP.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Correspondent Contact ANNE MARIE CESARIO
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/27/1996
Decision Date 05/22/1996
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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