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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 K842999
Device Name VENI-SHIELD
Applicant
U.S. Mfg. & Management, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
U.S. Mfg. & Management, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5210
Classification Product Code
KMK  
Date Received07/30/1984
Decision Date 09/24/1984
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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