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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K914034
Device Name INFUCARE SYRINGE PUMP TUBING SET
Applicant
Infucare Products, Inc.
917 Klosterman Rd.E
Tarpon Springs,  FL  34689
Applicant Contact DON RYAN
Correspondent
Infucare Products, Inc.
917 Klosterman Rd.E
Tarpon Springs,  FL  34689
Correspondent Contact DON RYAN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/10/1991
Decision Date 10/30/1991
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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