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510(k) K981860

A P HARNESS by Paraworks Enterprise, Ltd. — Product Code KMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1999
Date Received
May 27, 1998
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

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