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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K861494
Device Name EMPTY SOLUTION TRANSFER CONTAINER 1,500 ML
Applicant
POLYMER TECHNOLOGIES
369 N. NEWCOMB ST.
WHITEWATER,  WI  53190
Applicant Contact DAVID D PLEKENPOL
Correspondent
POLYMER TECHNOLOGIES
369 N. NEWCOMB ST.
WHITEWATER,  WI  53190
Correspondent Contact DAVID D PLEKENPOL
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/22/1986
Decision Date 08/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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