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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 NORTH NEWCOMB ST.
WHITWATER,  WI  53190
Applicant Contact DAVID D PLEKENPOL
Correspondent
POLYMER TECHNOLOGY CORP.
369 NORTH 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
Recalls CDRH Recalls
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