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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K940258
Device Name SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)
Applicant
Incutech, Inc.
307-A S. Westgate Dr.
Greensboro,  NC  27407
Applicant Contact ROGER V MOLINA
Correspondent
Incutech, Inc.
307-A S. Westgate Dr.
Greensboro,  NC  27407
Correspondent Contact ROGER V MOLINA
Regulation Number880.5025
Classification Product Code
KPE  
Date Received01/21/1994
Decision Date 03/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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