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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K905415
Device Name BRAIDED HIGH PRESSURE CATHETER CONNECTOR
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 Number880.5200
Classification Product Code
FOZ  
Date Received12/04/1990
Decision Date 08/12/1991
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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