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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 K860818
Device Name ONE TIME ENTERAL FEEDING BAG
Applicant
ACME UNITED CORP.
425 POST RD.
FAIRFIELD,  CT  06430
Applicant Contact SUSAN L CAREY
Correspondent
ACME UNITED CORP.
425 POST RD.
FAIRFIELD,  CT  06430
Correspondent Contact SUSAN L CAREY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/04/1986
Decision Date 05/15/1986
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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