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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K913267
Device Name R-GROUP INTL. ONE WALL PUNCTURE NEEDLE
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 Number870.1390
Classification Product Code
DRC  
Date Received07/23/1991
Decision Date 06/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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