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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 K860071
Device Name HOLD-IT FRAMED ADHESIVE FILM
Applicant
Vlv Associates, Inc.
30 Ridgedale Ave.
East Hanover,  NJ  07936
Applicant Contact V. L VAILLANCOURT
Correspondent
Vlv Associates, Inc.
30 Ridgedale Ave.
East Hanover,  NJ  07936
Correspondent Contact V. L VAILLANCOURT
Regulation Number880.5210
Classification Product Code
KMK  
Date Received01/06/1986
Decision Date 01/27/1986
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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