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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 K941098
Device Name SECURE-SITE
Applicant
Op-Co Medical Products , Ltd.
30 Rockefeller Plz.
Rm. 5455
New York City,  NY  10112
Applicant Contact JANICE COOK
Correspondent
Op-Co Medical Products , Ltd.
30 Rockefeller Plz.
Rm. 5455
New York City,  NY  10112
Correspondent Contact JANICE COOK
Regulation Number880.5210
Classification Product Code
KMK  
Date Received03/09/1994
Decision Date 08/09/1995
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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