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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Catheter
510(k) Number K952470
Device Name ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.
Applicant
R-Group Intl.
P.O. Box 7235
2321 NW 66th Ct., Suite W4
Gainesville,  FL  32653
Applicant Contact KERRY ANNE KAHN
Correspondent
R-Group Intl.
P.O. Box 7235
2321 NW 66th Ct., Suite W4
Gainesville,  FL  32653
Correspondent Contact KERRY ANNE KAHN
Regulation Number878.4200
Classification Product Code
GCD  
Date Received05/26/1995
Decision Date 11/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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