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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 K895431
Device Name JOHNSON & JOHNSON TUBE SECUREMENT DEVICE
Applicant
Johnson & Johnson Patient Care, Inc.
410 George St.
New Brunswick,  NJ  08901
Applicant Contact MC CANN
Correspondent
Johnson & Johnson Patient Care, Inc.
410 George St.
New Brunswick,  NJ  08901
Correspondent Contact MC CANN
Regulation Number880.5210
Classification Product Code
KMK  
Date Received09/06/1989
Decision Date 10/13/1989
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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