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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 K841487
Device Name INTRAVASCULAR CATHETER SECUREMENT DEV
Applicant
Tapemark Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Tapemark Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5210
Classification Product Code
KMK  
Date Received04/10/1984
Decision Date 06/28/1984
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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