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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 K924369
Device Name ILS(TM) - INVASIVE LINE SEPARATOR
Applicant
2-Rn Corp.
P.O. Box 361183
Melbourne,  FL  32936
Applicant Contact JUDITH V SIMPSON
Correspondent
2-Rn Corp.
P.O. Box 361183
Melbourne,  FL  32936
Correspondent Contact JUDITH V SIMPSON
Regulation Number880.5210
Classification Product Code
KMK  
Date Received08/28/1992
Decision Date 02/05/1993
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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