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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 K912660
Device Name SECURODRIP
Applicant
OP-CO MEDICAL PRODUCTS LTD.
747 THIRD AVE.
NEW YORK,  NY  10017
Applicant Contact SUSAN C STOLZER
Correspondent
OP-CO MEDICAL PRODUCTS LTD.
747 THIRD AVE.
NEW YORK,  NY  10017
Correspondent Contact SUSAN C STOLZER
Regulation Number880.5210
Classification Product Code
KMK  
Date Received06/17/1991
Decision Date 12/04/1991
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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