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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K884792
Device Name VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES
Applicant
Infucare Products, Inc.
917 Klosterman Rd.E
Tarpon Springs,  FL  34689
Applicant Contact JOSEPH E HARMS
Correspondent
Infucare Products, Inc.
917 Klosterman Rd.E
Tarpon Springs,  FL  34689
Correspondent Contact JOSEPH E HARMS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/15/1988
Decision Date 01/30/1989
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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