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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K860706
Device Name IV BAND (INTRAVENOUS CATHETER ASSESORY)
Applicant
T. G. & E. Medical
125 E. Idaho, Suite 105
Boise,  ID  83712
Applicant Contact TALBOY, JR.
Correspondent
T. G. & E. Medical
125 E. Idaho, Suite 105
Boise,  ID  83712
Correspondent Contact TALBOY, JR.
Regulation Number880.5210
Classification Product Code
KMK  
Date Received02/26/1986
Decision Date 03/21/1986
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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