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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K942931
Device Name STATLOCK SECUREMENT DEVICES
Applicant
Venetec, Inc.
5310 Ward Rd., Suite G-07
Arvada,  CO  80002
Applicant Contact PATRICIA AMTOWER
Correspondent
Venetec, Inc.
5310 Ward Rd., Suite G-07
Arvada,  CO  80002
Correspondent Contact PATRICIA AMTOWER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/22/1994
Decision Date 03/28/1995
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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