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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 K896421
Device Name TRANSPARENT FILM I.V. SITE/WOUND DRESSING
Applicant
Catalina Biomedical Corp.
1850 Evergreen St.
Duarte,  CA  91010
Applicant Contact J ROGOZINSKI
Correspondent
Catalina Biomedical Corp.
1850 Evergreen St.
Duarte,  CA  91010
Correspondent Contact J ROGOZINSKI
Regulation Number880.5210
Classification Product Code
KMK  
Date Received11/08/1989
Decision Date 01/31/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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