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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 K110794
Device Name AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
Applicant
Ameco Medical Industries
79 Brookline Rd.
Mason,  NH  03048
Applicant Contact Ray Kelly
Correspondent
Ameco Medical Industries
79 Brookline Rd.
Mason,  NH  03048
Correspondent Contact Ray Kelly
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/22/2011
Decision Date 12/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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