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510(k) K935252

K-LOK CATHETER SECUREMENT DEVICE MODIFICATION by K-Lok, Inc. — Product Code KMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1994
Date Received
October 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Intravascular Catheter Securement
Device Class
Class I
Regulation Number
880.5210
Review Panel
HO
Submission Type

Other clearances by K-Lok, Inc.

  • K930225 — K-LOK CATHETER SECUREMENT DEVICE (April 21, 1993)

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  • K935389 — CONMED VENI-GARD I.V. DRESSING (March 7, 1994)
  • K940127 — CENTERMARK SECURING WINGS (February 9, 1994)