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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 K843523
Device Name EMPTY SOLUTION TRANSFER CONTAINER 1000
Applicant
Polymer Technology Corp.
369 N. Newcomb St.
Whitwater,  WI  53190
Applicant Contact DAVID D PLEKENPOL
Correspondent
Polymer Technology Corp.
369 N. Newcomb St.
Whitwater,  WI  53190
Correspondent Contact DAVID D PLEKENPOL
Regulation Number880.5025
Classification Product Code
KPE  
Date Received09/07/1984
Decision Date 10/16/1984
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
Recalls CDRH Recalls
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