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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 K940319
Device Name R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE
Applicant
R-Group Intl.
P.O. Box 7235
2321 NW 66th Ct., Suite W4
Gainesville,  FL  32653
Applicant Contact MARK J KAHN
Correspondent
R-Group Intl.
P.O. Box 7235
2321 NW 66th Ct., Suite W4
Gainesville,  FL  32653
Correspondent Contact MARK J KAHN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/24/1994
Decision Date 11/10/1994
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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