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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name connector, airway (extension)
510(k) Number K940544
Device Name DOUBLE TRACH SEIVEL CONNECTOR
Applicant
FVTNKS
10415 BRIGGS CT.
INDIANAPOLIS,  IN  46256 -9719
Applicant Contact PAUL E DRYDEN
Correspondent
FVTNKS
10415 BRIGGS CT.
INDIANAPOLIS,  IN  46256 -9719
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5810
Classification Product Code
BZA  
Date Received02/07/1994
Decision Date 04/19/1994
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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