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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
Predetermined Change
Control Plan Authorized		 No
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