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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 K885173
Device Name MIX CONTAINER W/ATTACHED TRANSFER SET
Applicant
Medical Support Systems
9825 Lackman Rd.
Lenexa,  KS  66215
Applicant Contact LOREN GOTTSCHALK
Correspondent
Medical Support Systems
9825 Lackman Rd.
Lenexa,  KS  66215
Correspondent Contact LOREN GOTTSCHALK
Regulation Number880.5025
Classification Product Code
KPE  
Date Received12/13/1988
Decision Date 06/07/1989
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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