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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K861015
Device Name ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS
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 Number880.5200
Classification Product Code
FOZ  
Date Received03/18/1986
Decision Date 04/22/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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