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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K924243
Device Name TRACHEOSTOMY CARE KIT
Applicant
Transidyne General Corp.
400 Herald Journal Park
Spartanburg,  SC  29303
Applicant Contact STEVEN W BUTLER
Correspondent
Transidyne General Corp.
400 Herald Journal Park
Spartanburg,  SC  29303
Correspondent Contact STEVEN W BUTLER
Regulation Number868.5800
Classification Product Code
JOH  
Date Received08/24/1992
Decision Date 06/16/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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