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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K924811
Device Name I.V. START KIT
Applicant
Transidyne General Corp.
400 Herald Journal Park
Spartanburg,  SC  29303
Applicant Contact BUTLER
Correspondent
Transidyne General Corp.
400 Herald Journal Park
Spartanburg,  SC  29303
Correspondent Contact BUTLER
Regulation Number880.5200
Classification Product Code
LRS  
Date Received09/25/1992
Decision Date 06/17/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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