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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 K935252
Device Name K-LOK CATHETER SECUREMENT DEVICE MODIFICATION
Applicant
K-LOK, INC.
1120 HOLLAND DR.
SUITE 14
BOCA RATON,  FL  33487
Applicant Contact GLENDA KALT
Correspondent
K-LOK, INC.
1120 HOLLAND DR.
SUITE 14
BOCA RATON,  FL  33487
Correspondent Contact GLENDA KALT
Regulation Number880.5210
Classification Product Code
KMK  
Date Received10/07/1993
Decision Date 02/18/1994
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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