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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K911549
Device Name INJECTOR FILL TUBE
Applicant
The R Group
P.O. Box 7235 Suite W4
2321 Northwest 66th Court
Gainesvilles,  FL  32605
Applicant Contact MARK J KAHN
Correspondent
The R Group
P.O. Box 7235 Suite W4
2321 Northwest 66th Court
Gainesvilles,  FL  32605
Correspondent Contact MARK J KAHN
Regulation Number870.1650
Classification Product Code
DXT  
Date Received04/08/1991
Decision Date 07/18/1991
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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