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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 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 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
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