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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 K001233
Device Name ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
Applicant
R-GROUP INTL.
2321 N.W. 66TH CT., SUITE W-4
GAINESVILLE,  FL  32653
Applicant Contact KERRY ANNE KAHN
Correspondent
R-GROUP INTL.
2321 N.W. 66TH CT., SUITE W-4
GAINESVILLE,  FL  32653
Correspondent Contact KERRY ANNE KAHN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/17/2000
Decision Date 12/13/2000
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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