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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K905416
Device Name VESSEL DILATOR
Applicant
The R Group
P.O. Box 7235 Suite W4
2321 Northwest 66th Ct.
Gainesvilles,  FL  32605
Applicant Contact MARK J KAHN
Correspondent
The R Group
P.O. Box 7235 Suite W4
2321 Northwest 66th Ct.
Gainesvilles,  FL  32605
Correspondent Contact MARK J KAHN
Regulation Number870.1310
Classification Product Code
DRE  
Date Received12/04/1990
Decision Date 03/25/1991
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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