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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 K930225
Device Name K-LOK CATHETER SECUREMENT DEVICE
Applicant
K-Lok, Inc.
7676 Ct.yard Run W.
Boca Raton,  FL  33433
Applicant Contact GLENDA KALT
Correspondent
K-Lok, Inc.
7676 Ct.yard Run W.
Boca Raton,  FL  33433
Correspondent Contact GLENDA KALT
Regulation Number880.5210
Classification Product Code
KMK  
Date Received01/15/1993
Decision Date 04/21/1993
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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