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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Feeding
510(k) Number K870623
Device Name ENTERAL ADMINISTRATION SET
Applicant
Plasco, Inc.
3849 Swanson St.
Gurnee,  IL  60031
Applicant Contact MICHAEL S FELES
Correspondent
Plasco, Inc.
3849 Swanson St.
Gurnee,  IL  60031
Correspondent Contact MICHAEL S FELES
Regulation Number876.5980
Classification Product Code
FPD  
Date Received02/12/1987
Decision Date 06/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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