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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K895480
Device Name BLUNT NEEDLE PORT/I.V. PORT
Applicant
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Applicant Contact DEAN SECREST
Correspondent
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Correspondent Contact DEAN SECREST
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/11/1989
Decision Date 12/01/1989
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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