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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 K904886
Device Name VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS
Applicant
Florida Infusion Services, Inc.
800 U.S. Hwy. 19 S.,
#32a
Tarpon Springs,  FL  34689
Applicant Contact RUDY CICCARELLO
Correspondent
Florida Infusion Services, Inc.
800 U.S. Hwy. 19 S.,
#32a
Tarpon Springs,  FL  34689
Correspondent Contact RUDY CICCARELLO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/26/1990
Decision Date 01/11/1991
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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