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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 K963365
Device Name MULTI-PURPOSE MEDICAL TUBE HOLDER
Applicant
BYRD MEDICAL DEVICES, INC.
111 CENTER PARK DR., SUITE 200
KNOXVILLE,  TN  37922
Applicant Contact TIM BYRD
Correspondent
BYRD MEDICAL DEVICES, INC.
111 CENTER PARK DR., SUITE 200
KNOXVILLE,  TN  37922
Correspondent Contact TIM BYRD
Regulation Number880.5210
Classification Product Code
KMK  
Date Received08/27/1996
Decision Date 10/11/1996
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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