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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 K930197
Device Name KWIK BOARD
Applicant
Astral, Ltd.
44 Mark Dr.
San Rafael,  CA  94903
Correspondent
Astral, Ltd.
44 Mark Dr.
San Rafael,  CA  94903
Regulation Number880.5210
Classification Product Code
KMK  
Date Received01/14/1993
Decision Date 04/20/1993
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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